FDA 510(k) competitive intelligence, without the analyst retainer.
Clearance Wire watches your product codes and connects the dots the raw FDA data never hands you: who cleared what, which predicates are getting recalled, and where adverse-event reports are moving. One weekly brief, plus alerts the day new data lands.
What the intelligence actually is
Three connected signals, all from public FDA data.
Competitor clearances
Every new 510(k) in your product codes, joined to its device name, applicant, and decision date. You see market entries the day FDA publishes them, not when they show up in a launch deck.
Predicate recalls
Clearances are linked to their predicates, and predicates to recalls. When a predicate device gets recalled, everyone downstream of it needs to know. We flag it.
Adverse-event movement
MAUDE report counts per product code, watched for spikes. We report counts and trends only. We never assert that a device caused an event, because a report existing does not establish causation.
Sample watchlist demo
Build a watchlist below, then generate the sample brief. Everything in the brief is clearly labeled sample data, so you can see exactly what subscribers get every week.
Sample data for demonstration. The paid brief is built from live FDA data every week.
Who uses this
Anyone whose week gets worse when they learn about a clearance secondhand.
Regulatory consultants
One seat covers every client. Run a separate watchlist per client, walk into every meeting already knowing what cleared, what got recalled, and where the reports are moving.
Founders and strategy teams
See who is entering your product code and which predicates are getting shaky, before it shows up in a competitor's launch deck. Competitive intel without the analyst retainer.
FAQ
Straight answers.
Where does the data come from?
Public FDA databases through openFDA: 510(k) clearances, recalls, and MAUDE adverse events. Public domain, no scraping, no API key.
Do you claim a device caused an injury?
Never. Adverse event reports are unverified: they can be incomplete, inaccurate, or biased, and a report existing does not establish causation. We report counts and trends, never causation.
Is this regulatory advice?
No. Clearance Wire surfaces public data and joins it up so you can see what moved. Your regulatory decisions stay with you and your advisors.
What does the demo brief use?
Built-in sample data, every card labeled. The paid product builds the same brief shape from live FDA data.
Get the real brief, weekly
$49 a month. Your product codes watched daily, a weekly brief in your inbox, alerts the day a competitor clears, a predicate is recalled, or reports spike.
Start watching your codes