Your competitor’s 510(k), decoded before your Monday meeting.
Clearance Wire is a weekly 510(k) brief for med-device founders and regulatory consultants, built on public FDA data.
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We will email your free brief shortly. If you gave us product codes, they are already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
The week you find out secondhand is the week you lose
FDA publishes every clearance. The question is whether you see it before everyone else does.
Competitive blind spots
Learning about a rival’s clearance from their press release, weeks after FDA published it, when your roadmap already assumed they were quiet.
Missed recall signals
Not noticing when a device you rely on gets recalled or racked with adverse events, until a reviewer asks about it or a client does.
Regulatory surprises
Walking into a board meeting or client call without knowing what cleared this week in your codes, and getting briefed by someone else in the room.
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 checked against recalls and enforcement records, with recall-to-clearance links drawn where the records cite a K number. 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 when new data lands: a competitor clearance, a recall touching your codes, 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 GEX: K262877, SOLTIVE Laser System, cleared September 16, 2026. Applicant: Olympus Surgical Technologies America.
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, where recalls are clustering, and where the field is heading, before it shows up in a competitor's launch deck.
This is the kind of pattern your brief flags
From the September 29, 2026 records: 6 of the 7 clearances that day were laser devices under product code GEX. A subscriber watching GEX will see the whole cluster flagged in one brief, with the one outlier called out.
Six GEX laser clearances in one day: Fotona Dynamis Pro Family (K252723), Lumenis SmartIPL_NI System (K241973), Olympus SOLTIVE Laser System (K262877), Guilin Kevin Peter Dental Diode Laser Device (K261047), Zhengzhou PZ Laser Diode Laser Therapy System (K261817), and Beijing Nubway LED Therapy Device (K261673).
Pricing
One plan. Everything included. Monthly or annual.
- 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
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. Cancel anytime. Secure checkout via Stripe.
7-day money-back guarantee: reply within 7 days of your first charge for a full refund. The free brief needs no card.
- Everything in monthly, two months free
- One invoice, one renewal date
$490 once a year. Starts with 7 days free, then $490/year. Cancel anytime. 7-day money-back guarantee on your first charge. Secure checkout via Stripe.
Consultancy or device company with a group to cover? See the Team plan (coming soon).
Investor tracking med-device positions? See the Investor plan (coming soon).
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.
Data as of October 11, 2026: at our last freshness check on October 22, 2026, the newest 510(k) record in the FDA feed was dated October 11, 2026 (11 days earlier). FDA publication lag is part of that gap, so a brief cannot include clearances FDA has not published yet.
How does the 7-day trial work?
The 7-day free trial applies to both plans: your card is on file and you pay nothing for 7 days. You get the full watchlist, daily alerts, and weekly brief from day one. Cancel before day 7 and you are never charged. After the trial it is $49/month on the monthly plan or $490/year on the annual plan, with a 7-day money-back guarantee on your first charge. Cancel anytime.
What is the refund policy?
7-day money-back guarantee. If Clearance Wire is not worth it, reply to any of our emails within 7 days of your first charge and we will refund it in full, no questions asked. If you have no email from us yet, write to [email protected].
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. Email [email protected] from your subscription address, or reply to any of our emails, and we will cancel it. 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, a recall touches your codes, or adverse events spike on your codes. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. Cancel anytime. Secure checkout via Stripe. Covered by the 7-day money-back guarantee.
Not ready? Get one free brief
Tell us where to send it. No card required.
You are on the list.
We will email your free brief shortly. If you gave us product codes, they are already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.