FDA market intelligence report
The public FDA data on your product code, gathered and explained in one report: who holds the clearances and how long FDA takes to review them, what your competitors submitted, adverse events and recalls, inspections, warning letters and import refusals. Add your company and your competitors, and the report also checks your own FDA records and compares you with them.
Classification, recognized standards, guidance and Federal Register notices for each code
510(k) clearances per year, who holds them, review times and the most recent clearances
Predicates, standards, tests and clinical data read from the public 510(k) summaries
Who is in the market: countries, new applicants, establishments and GUDID records
Adverse events by year, type, problem, manufacturer and brand, with the serious events explained
Recalls with their class, root cause and how long they stayed open
FDA inspections, 483 citations, warning letters and import refusals in your codes
With your company named: a check of your own FDA records, key risk signals and recommendations
Add a competitor
Product codes (up to 3)
Where you are
Your device in a sentence (optional)
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Your company (optional)
What the report includes
510(k) clearances in 10 years
The report is prepared automatically from public FDA data, and parts of it are written by AI. It is not reviewed by a person before it is sent, it is not legal or regulatory advice, and the company that uses it is responsible for checking it and for the decisions made on the basis of it.
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Your name
adverse event reports in 10 years
Launch price until {date}
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A product code has three letters, for example DQA.
recall records in 10 years
Use this code in the report
Something else
Your device's code, and the codes your competitors use if they are different.
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Not sure which code is yours? The 510(k), De Novo or PMA tool and the FDA product classification database will help you find it.
The full report breaks these numbers down by year, firm, problem and cause, and adds inspections, 483 citations, warning letters, import refusals and what your competitors submitted to FDA.
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Enter the three-letter FDA product code to see the classification and three numbers from the last 10 years.
Asking the FDA…
Sources: openFDA, FDA accessdata, the FDA Data Dashboard and the Federal Register, for the last 10 years. Every number in the report comes from these sources, and the explanations are written by AI from those numbers.
The report is prepared automatically from the FDA data of the day the payment is received, and the link is sent to you by email, usually on the same day.
Competitors (optional, up to 3)
Company country
Class
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A first look at your product code
The price comes with the payment details.
Cleared and on the market
As it appears in FDA records. Adds a chapter on your own clearances, adverse events, GUDID records, recalls and inspections.
Show the numbers
Planning a 510(k)
Please enter at least one product code.
510(k) submitted
Firm names as they appear in FDA records. The report shows their clearances and any product codes they use outside yours.
No
510(k) clearances in 10 years ({codes})
Over the counter
What this shows
Yes
510(k) clearances held by {name}
adverse event reports in 10 years
Open
PART {p}
Sections cited in {code} Form 483s ({n} citations)
{code}: new applicants per year
{code}: {n} registered establishments, by activity
{code}: {n} device identifiers in GUDID
K number
Download the data (Excel)
recall events in 10 years
registered establishments
initial manufacturer reports with both dates
Print or save as PDF
Product codes {codes}
{code}: {n} device inspections at {firms} firms
Reports by manufacturer (sites added up)
All read
Closed
Tables and charts come from FDA data. Gold boxes are written by AI from those numbers.
Pulled from the FDA on {date} and counted by product code, from {since}: openFDA (classification, 510(k), adverse events, recalls, enforcement, registration and listing, GUDID), FDA accessdata (classification pages, recognized standards, 510(k) summaries), the FDA Data Dashboard (inspections, citations, compliance actions, import refusals) and the Federal Register. Predicates, standards, clinical data and indications were read by AI from {n} public 510(k) summaries. Company records were found by the company name as written in the order.
At a glance
Regulatory position
Getting to market: 510(k)
The market
Post-market safety
Inspections and enforcement
Your own records
Signals and recommendations
Federal Register since {since}
Third-party review eligible
Recommendations
AI
FDA root cause, by recall event
Type of submission
MDR timeliness
Recalls
Registration and listing
GUDID records
MDR
MRI safety
No document names 21 CFR {reg}
{code}: most refusals from {country} ({n}); firm refused most often {firm} ({fn}).
This report was not found. Please check the link in your email.
FDA definition
GMP exempt
Regulation, class and panel
Summary malfunction reporting
Not over the counter
Classification and product code position
from FDA data
Reports by brand name, as written in the reports
Who reported
Most recent clearances
FDA inspections
None
510(k)s
Area
Code
Date
Days
Firm
FDA root cause
What the report says
Type
Contents
Eligible
Based on the {sample} most recent reports naming the company. The date the manufacturer received the information can be the date of later information; 21 CFR 803.50 counts 30 days from awareness of a reportable event.
Prepared {date} from FDA data since {since}
Adverse events
Who is in the market
Method and sources
Review times
{name}
Compliance actions since {since}
Event type
{code} reports per year
{code}: who holds the clearances (10 years)
Import refusals since {since}
Patient problems
Reasons, as FDA wrote them
{over} of {n} initial reports over 30 days by the MAUDE dates
{n} records; {flagged} with a data point to check
Information received
Based on
Brand
Check
Class
First clearance
To check
Model
Source: FDA Data Dashboard, device inspections since {since}, matched by the FEI numbers registered under each code, so they can include firms that also make other products. NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated. Citations before Feb 2, 2026 refer to the former QSR; the QMSR applies since then.
Not given
Your report is being prepared. You will receive the link by email as soon as it is ready.
reference device
This report is provided for information only. It is prepared automatically from public FDA data, and parts of it are written by AI. It is not reviewed by a person before it is sent, it is not legal or regulatory advice, and it is not an FDA determination. The company that uses the report is responsible for checking it against its own records and current FDA sources, and for every regulatory and business decision made on the basis of it. qualityworks. is not responsible for such decisions or for errors or gaps in the FDA data.
Class
Checks on {name}'s FDA records
Recalls
Recommendations for {name}
Serious events
Key risk signals
Executive summary
Clinical data
Labelers with the most identifiers
{code} clearances per year
Device problems
Standards named in {n} summaries
device not listed (118)
misbranded labeling (237)
facility not registered (341)
no PMA (476)
no 510(k) (508)
Action
Device
Recall
Report
Result
Signal
Status
MAUDE counts are not adjusted for units sold and are known to under-report; a report does not prove that a device caused an event.
median days from information received to FDA receipt
reports received more than 30 days later
No recall was initiated in these codes since {since}.
None found
Your responsibility
Charge: {charge}
Device
Numbers check: these numbers in the AI text were not found in the facts: {list}. Please check them before sending.
{code}: clearances by applicant country (all time, {n})
foreign manufacturer not registered (3280)
Result
Source: openFDA device adverse events (MAUDE). Counts are not adjusted for units sold, and a report does not prove that a device caused an event.
An establishment can list several activities. New applicants are firms with their first clearance in the code within the 10 years.
None listed on the classification page
Not checked
Product codes used outside this report
Days from FDA receipt to decision, including the time the file was on hold for questions.
Implant · life-sustaining
Median review days, all
Standards, guidance and regulatory changes
What competitors submitted
Reports naming {name}: {n} in 10 years
Clinical evidence
Decision
Evidence
Priority
FDA received
Severity
No product code
The FDA Data Dashboard did not answer when the report was prepared, so inspections and import refusals are not included.
Not eligible
Device-specific guidance
Median, Special 510(k)
Median, Traditional 510(k)
Refusals
Clearance landscape
Predicates
MDR reporting timeliness
The most recent death reports, then injury reports. A report means the event was reported, not that the device caused it.
{code}: median days from receipt to decision
GUDID records
510(k) summaries on the FDA site
Applicant
Days open
Initiated
FDA-recognized standards
Warning letters and import refusals
Indications for use
FDA inspections
from the 510(k) summaries
{n} in 10 years (lifetime {life}). Gold bars are partial years ({first} and {last}).
{firms} firms in 10 years; the top 3 hold {top3}%.
510(k) clearances
Predicates (as listed in the summary)
{n} requests to FDA sources did not return data when the report was prepared; the sections that depend on them may be incomplete.
Marked neither prescription nor over the counter
{n} of {total} summaries describe clinical data; {cyber} mention cybersecurity.
{name}'s clearances
{n} in 10 years (lifetime {life}). Gold bars are partial years ({first} and {last}).
Marked both prescription and over the counter
{n} in total, {w} in the last 10 years, in {codes}
Read from the indications for use in the most recent 510(k) summaries. Blank means the summary does not state it.
Summaries not available as a readable PDF on the FDA site: {list}.
Product code not among the company's clearances or listings
Not available or not readable: {list}
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