Know when a competitor clears, before your Monday meeting.
Clearance Wire watches your FDA product codes and pings you when a competitor clears, a predicate gets recalled, or adverse events spike. Built on public FDA data. Made for regulatory consultants and the founders they advise.
How it works
Three steps. No dashboards to babysit, no databases to query. We do the watching.
Pick your product codes
Tell us which FDA product codes cover your devices. Consultants run one watchlist per client, on a single seat.
We cross-link the data
Every clearance is joined to its predicates, every predicate to its recalls, every device to its adverse events. The connections raw FDA data never hands you.
Get the brief, plus pings on what matters
A weekly brief for your codes. And an alert the day FDA publishes a competitor clearance, a predicate recall, or an adverse-event spike.
What an alert looks like
Short, specific, with the source attached. No noise.
A new 510(k) cleared in product code HXL: K260312, cemented total knee prosthesis, cleared September 12, 2026. Applicant: a company you compete with. Predicate: K193881.
Who it is for
Anyone whose week gets worse when they learn about a clearance secondhand.
Regulatory consultants
One seat covers every client. Watch each client's codes separately, walk into every meeting already knowing what cleared, what got recalled, and where the adverse events are moving.
Founders and strategy teams
Competitive intel without the analyst retainer. See who is entering your product code, which predicates are getting shaky, and where the field is heading, before it shows up in a competitor's launch deck.
Pricing
One plan. Everything included.
- Watch unlimited product codes
- Weekly brief, plain English
- Alerts the day new data lands: competitor clearances, predicate recalls, adverse-event spikes
- Built for consultants: one seat, every client
- Cancel anytime
FAQ
Straight answers.
Where does the data come from?
Public FDA databases, through openFDA: 510(k) clearances, recalls, enforcement reports, and MAUDE adverse events. The data is public domain. No API key, no scraping, no backdoor access.
Is this regulatory advice?
No. Clearance Wire is not regulatory advice and not a substitute for counsel. We surface public data and join it up so you can see what moved. Your regulatory decisions stay with you and your advisors.
What is the FDA disclaimer on this data?
We carry it verbatim, from openFDA:
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
Terms: open.fda.gov/terms. License: open.fda.gov/license.
How fresh is the data?
FDA typically publishes new 510(k) records about a week after the decision date. Recalls land faster, adverse events slower. We poll the data daily and alert you the same day new records appear. We also run a freshness check on every feed, so if FDA goes quiet, we will tell you that too.
Do your summaries claim a device caused an injury?
Never. Adverse event reports are unverified by nature: they can be incomplete, inaccurate, or biased, and a report existing does not establish causation. We report counts and trends. We never assert that a device caused an event.
Who is this for, exactly?
Regulatory consultants first: one subscription covers every client you advise, which makes it an easy expense to justify. Med-device founders and BD or strategy teams second.
Can I cancel?
Anytime. No calls, no retention flow.
Get Clearance Wire
$49 a month. Your product codes watched daily. A weekly brief in your inbox. An alert the day a competitor clears, one of your predicates is recalled, or adverse events spike on your codes. Cancel anytime.
Start watching your codes
Tell us where to send your first brief. We will set up your watchlist from there.
You are on the list.
We will email you when your first brief is ready. If you gave us product codes, they are already in your watchlist draft.