FDA 510(k) · RECALLS · MAUDE · PREDICATES
Nobody tells you when a device in your code is recalled.
FDA won't. The manufacturer won't. DeviceSignal watches every clearance, recall and adverse-event report in the product codes you follow, and emails you the morning anything changes.
Free. No account needed.
This is what the job looks like today.
Today
- Open the 510(k) database
- Open the recall database
- Open MAUDE separately
- Copy it all into Excel
- Fix the same company name spelt four ways
- Do it all again next Monday
≈ 3 to 5 hours, every week
With DeviceSignal
- Type the product code once
- See every dataset on one page
- Click Watch
- An email arrives when anything changes
≈ 5 minutes, then it runs itself
What we watch
A blank predicate chain is not a clean one.
FDA publishes no machine-readable predicate field — the references sit inside each 510(k) summary PDF — so nobody can hand you a complete ancestry, and a tool that shows an empty list is telling you it found nothing when it means it never looked. We say which. Meanwhile we do watch what is published: every open recall, adverse-event spike and first-time filer in the codes you follow, and you hear the morning something moves.
- Your device: the device being examined.
- K231902: 1 generation up.
- K201455: 2 generations up. Class II recall. Aug 2026.
- K173388: 3 generations up.
- 1976: 4 generations up. grandfathered.
Class II recallA device in this chain has been recalled
Substantial equivalence was argued against a device that FDA later recalled. That does not make this device unsafe, and it is worth knowing before someone else points it out.
4 generations read from summaries we hold. FDA publishes no predicate field, so this may not be the whole chain.
Two recalls opened in QIH in the last 12 months and not yet terminated.
Sourced to Z-2371-2026 and Z-1913-2026, with FDA's own record ids.
The email
One email, before you open your laptop.
Everything that changed in the codes you watch, ordered by what it costs you if you miss it. On a quiet day the daily email doesn't go out at all; the weekly one still arrives, listing every source we checked and when — so a calm week never looks like a broken one.
- RecallK201455Class II · QIHSits in 3 of your saved predicate chains.
- SpikeLLZMAUDE · 30-day windowReports running 3.4× this code's 12-month baseline.
- ClearanceK253012QIH · decision 07 AugNew entrant. First filing in this code since February.
Every line links to the FDA record it came from.
The free tools tell you what exists. This tells you what it means.
Daily Intelligence Digest
One paragraph per code, joining clearances, recalls, adverse events and predicate ancestry — ordered by consequence, with the record ID behind every clause.
One Name Across Six Datasets
MEDTRONIC, INC. in a recall and Medtronic Inc in a registration are one company here. Normalising one dataset is common; holding identity across all six is what makes a joined count possible.
Clean Excel Export
Real date types, frozen headers, and a metadata sheet recording exactly what was queried and when.
The landscape
The other tools are good. They just don't watch.
Regulatory teams already have software. Most of it is genuinely useful, and none of it does this particular job — which is why the job is still being done by hand every Monday.
Free clearance search
Good at
Fast lookup of a 510(k), a predicate graph, the summary PDF. Free, and often excellent.
Where it stops
One dataset, one moment in time. You have to remember to go back, and nothing tells you when a predicate gets recalled.
Submission copilots
Good at
Drafting a substantial-equivalence matrix, assembling a submission, mapping standards.
Where it stops
They help you file. After you file, the code keeps moving and the tool has stopped looking.
Post-market dashboards
Good at
Real signal-detection maths on adverse events, with proper baselines.
Where it stops
Adverse events only, and it is still a dashboard — it waits for you to open it.
DeviceSignal is the fourth kind.
It watches all six datasets against the codes you follow, and the output is an email, not a login.
Coverage
Six datasets, one page, every number sourced.
The same public FDA data everybody else has. The difference is that it arrives joined up, spelt consistently, and with its receipts attached.
| Dataset | openFDA endpoint | What it answers |
|---|---|---|
| 510(k) clearances | device/510k | Who cleared what, when, and against which predicate. |
| PMA | device/pma | Premarket approvals and their supplements. |
| Recalls | device/recall | Recall class, reason, and the devices affected. |
| Adverse events | device/event | MAUDE reports, by device and by product code. |
| Registration & listing | device/registrationlisting | Who is registered to make a device in this code. |
| UDI | device/udi | Device identifiers, brand names and the GUDID record. |
All six ingested daily at 03:00 UTC.
Source Trail
Every figure on a Code Page carries the FDA record ID it came from and the time we retrieved it. You can check any number against FDA's own database in one click — which is what your auditor is going to ask you to do.
AI Assistant Access
Point Claude or ChatGPT at DeviceSignal and ask in plain language. It queries our data directly and answers with record IDs — we do not put a language model between you and the FDA record.
{
"mcpServers": {
"devicesignal": {
"url": "https://mcp.devicesignal.com"
}
}
}Built for the person who gets blamed.
Regulatory consultant
One search that serves twenty clients.
Regulatory manager
Same-day alerts on your codes.
Post-market / quality
Complaint spikes flagged against baseline.
Business development
See who is entering your category.
Simple pricing.
Everything each plan includes — and everything it doesn't.
Free
$0forever
For anyone who lands here from Google.
- Included: Code Pages
- Included: Company Pages
- Included: One Search Box
- Included: MAUDE Lookup
- Included: Recall Lookup
- Included: Source Trail
- Included: AI Assistant Access
- Included: Predicate Preview — one generation up
- Included: Watch List — up to 3 codes
- Included: Review Time Benchmarks
- Included: Crowding Index
- Included: New Entrant Alerts — last 90 days
Not included
- Not included: Daily Intelligence Digest
- Not included: Predicate Risk Check
- Not included: Recall Blast Radius
- Not included: Clean Excel Export
- Not included: Full History
Submission Pass
Start here$49once — 7 days
For one submission. Pay once; nothing recurs.
- Included: Everything in Free
- Included: Watch List — up to 10 codes
- Included: New Entrant Alerts — full history, not 90 days
- Included: Daily Intelligence Digest
- Included: Predicate Risk Check
- Included: Predicate Explorer
- Included: Recall Blast Radius
- Included: Spike Alerts
- Included: Clean Excel Export
- Included: Shareable Snapshot
- Included: Full History — back to 1976
- Included: Since You Last Looked
- Included: Print & PDF Pack
- Included: Client-Ready PDF
- Included: One charge. No subscription, no card kept on file.
Not included
- Not included: Portfolio Monitoring
Everything, for seven days — then it stops on its own.
Checkout opening soonMonitor
$99/month
For watching the codes you file in, continuously.
- Included: Everything in the Submission Pass
- Included: Watch List — up to 10 codes
- Included: Cancel any time, keep the month you paid for
- Included: Price locked while you stay subscribed
Not included
- Not included: Client-Ready PDF
- Not included: Portfolio Monitoring
Checkout opening soonPortfolio
For consultants$199/month
For running several clients' codes at once.
- Included: Everything in Monitor
- Included: Watch List — unlimited codes
- Included: Client-Ready PDF
- Included: Portfolio Monitoring
- Included: Priority support
Not included
- Not included: Team Seats
- Not included: Shared Watch Lists
- Not included: Annual Invoice & PO
Checkout opening soon
What an hour of this costs you now.
- Checking one predicate chain by hand in the FDA database
- 30–45 min
- The same check here
- 2 seconds
- One senior regulatory consultant hour
- $150–250
- Submission Pass
- $49 once
At $200 an hour, the pass pays for itself on the second lookup. That is the whole argument — we are not competing with another tool, we are competing with your afternoon.
Billed in USD by Paddle, our Merchant of Record, who handle sales tax and VAT. The Submission Pass is a single charge — no subscription, and we keep no card on file. Monitor and Portfolio cancel from your account page, and you keep the period you have paid for.
Annual billing and team seats are not sold yet — we would rather not take money for a renewal cycle we have not run. Tell us if you need one and you will be first when they open.
Questions.
Is this data official?
Every figure comes from FDA's public openFDA datasets. We show the source record ID and the retrieval timestamp beside every number so you can verify it. We are not affiliated with FDA.
What is the Submission Pass?
$49 once, for seven days of everything. It exists because most people arrive here mid-submission with one question — is this predicate safe, what is happening in this code — and a monthly subscription is the wrong shape for one question. There is no subscription to cancel and we keep no card on file. It replaced a $49-per-week plan, which billed out at more than twice the monthly price and was a pricing mistake on our part.
How fresh is it?
We ingest every dataset daily at 03:00 UTC. The exact last-update time for each dataset is always on our status page.
Isn't FDA data already free?
Yes. The data is free and messy, split across six systems, with company names spelt several ways and no alerts. We sell the cleaning and the watching, not the data.
How is this different from the free 510(k) search tools?
They are good, and for looking up a single clearance you should keep using them. The difference is that a search tool waits to be opened. DeviceSignal joins clearances, recalls and adverse events for the codes you follow, flags a recall anywhere in a predicate chain, and emails you when something moves. Lookup is the part everyone does; watching is the part nobody does.
Is there AI in this? Does it summarise the records?
No. We do not paraphrase FDA records or generate interpretations of them — every figure is the record, with its ID and retrieval time beside it. The only AI involved is on your side: Claude or ChatGPT can query us directly, and the answers come back with the record IDs so you can check them.
Do I need to talk to sales?
No. Card payment, instant access, cancel from your account page. Only yearly and team plans involve a conversation.
Does it cover Europe?
Version 1 is US FDA data only. EUDAMED is not included.
Find out first, not three months late.
Start with any product code. No account needed.
Or check one submission for $49 — once, no subscription.