One plan for a few codes, one for a whole portfolio.
Both plans include the daily alert email, the Monday brief and recalls linked to their 510(k)s. Billed monthly in US dollars. Cancel in one click, with a full refund if you cancel within 14 days of your first payment.
For a consultant or startup following a handful of device types.
- 5 product codes on your watchlist
- Daily email with new 510(k)s and recalls for those codes
- Monday brief of the week, ready to forward
- Each recall linked to the 510(k) it names
- Search and full history for every code
- CSV export, up to 1,000 rows per file
For firms watching many clients or a full product line.
- 25 product codes on your watchlist
- Daily email with new 510(k)s and recalls for those codes
- Monday brief of the week, ready to forward
- Each recall linked to the 510(k) it names
- Search and full history for every code
- CSV export, up to 10,000 rows per file
- REST API, 60 requests a minute (docs)
Payment by Stripe. Your account is created after payment and we email you a sign-in link.
Questions
Where does the data come from?
Public FDA databases (510(k) decisions, device recalls and product classification) via openFDA, updated nightly. We are not affiliated with the FDA.
How are recalls linked to clearances?
Many FDA recall records list the 510(k) numbers of the recalled device. We link exactly those. We don't guess predicate relationships.
Can I try it first?
Yes. The free sample brief shows what the emails contain for any product code.
How do I cancel?
One button in your account. No calls, no notice period.