Clearance Wire

Know what cleared, who cleared it, and what it means for your positions.

Clearance Wire for Investors is a proposed plan for investors tracking med-device: competitive intelligence across FDA product codes, predicate chains that show R and D direction, and regulatory risk flags on positions and pipelines. Built on public FDA data. $299/month. Coming soon.

Notify me See a sample brief
510(k) clearances, tracked daily Predicate chains, linked per clearance Recalls and MAUDE events, flagged per code All public FDA data. No insider data.

What it covers

Three use cases, one watchlist per thesis.

Competitive intelligence

Watch product codes tied to your positions. See each new clearance with applicant, device name, K number, and decision date, the same week FDA publishes it.

M and A signals

See who is clearing what, and which predicates each clearance cites. Repeated filings against one predicate family can indicate where an acquirer or target is placing R and D effort.

Regulatory risk flags

Get flagged when a recall touches a watched code or when adverse events spike against a product code in your watchlist. Counts and trends only. We never assert causation.

How it works for investors

Three steps. We do the watching.

1

Map codes to positions

Tell us which FDA product codes map to each position or pipeline name you track. One watchlist holds them all, grouped by your labels.

2

We cross-link the data

Every clearance is checked against recalls and adverse event records, with predicate links attached. You get the clearance plus the context around it.

3

Get the brief and the flags

A weekly brief per watchlist, plus an alert the day a clearance, recall, or event spike lands on a code you track.

Pricing

The standard plan next to the proposed investor plan. The investor plan is not yet available.

$49/month
  • Watch unlimited product codes
  • Weekly brief in plain English, with per-code trend analysis like the laser cluster above
  • Recall and adverse-event linkage across your whole watchlist
  • Alerts the day new data lands: competitor clearances, recalls touching your codes, adverse-event spikes
  • Built for consultants: one seat covers every client
  • Cancel anytime
See the $49 plan

The $49/month plan is available now on the main page. Details above match that page.

$299/month
  • Everything in the $49 plan
  • Watchlists grouped by position or pipeline label
  • Predicate chain per clearance, with cited K numbers listed
  • Risk flags: recalls and adverse-event spikes mapped to your labels
  • CSV export of matched clearances, recalls, and flags
  • Cancel anytime
Notify me

Proposed plan. Not yet available. Leave your email below and we will write when it opens. No charge now.

Data sources

Built on public FDA data, nothing else.

Clearance Wire for Investors is built on public FDA databases through openFDA: 510(k) clearances, recalls, enforcement reports, and MAUDE adverse events. The data is public domain. There is no insider data, no nonpublic source, and no access beyond what any member of the public can query. Adverse event reports are unverified by nature and a report existing does not establish causation. Do not rely on openFDA to make decisions regarding medical care. Assume all results are unvalidated. Terms: open.fda.gov/terms. License: open.fda.gov/license.

FAQ

Straight answers.

What is covered?

US FDA 510(k) clearances, recalls, and MAUDE adverse events, through openFDA, for the product codes on your watchlist. Coverage is limited to what FDA publishes in those databases. There is no coverage of PMA filings beyond what the watched feeds contain, and no private company data.

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 flag new records the same day they appear. This is public record timing, not a real time feed.

Is access exclusive to my fund?

No. The investor plan carries no exclusivity. The same public records are available to every customer and to the public. Your watchlist labels stay private, but the underlying data is not exclusive to you.

Can I cancel anytime?

Yes. Monthly billing, cancel anytime. No calls, no retention flow.

Can I export the data?

Yes. The investor plan includes CSV export of matched clearances, recalls, and flags on your watchlist. Exports contain the same public record fields shown in the brief, with source links.

Is this investment advice?

No. Clearance Wire provides factual summaries of public FDA records. It is not investment advice, not a recommendation to transact in any security, and not a substitute for your own diligence. Regulatory and market decisions stay with you and your advisors.

Coming soon

The investor plan is not approved yet, so there is nothing to order. Leave your email and we will write when it opens, or write to us directly.