Grouped by specialty
Clearances sorted by FDA review panel: radiology, orthopedic, cardiovascular, dental, general surgery and more.
● SunHour Capital · FDA 510(k) Clearance Report
Every new FDA 510(k) clearance, every month.
- 278
- clearances in the sample issue
- 19
- FDA review panels covered
- 248
- distinct applicant companies
- Sep 12 – Oct 11
- 2026 sample window
01 What's inside
One month of clearances, organized for action.
Who cleared what
Device name, K number, product code, device class, regulation number and decision date for each clearance.
Applicant details
Applicant company, city, state and country as filed, plus the contact name listed on the FDA record.
Link to the source
Every row links straight to its FDA 510(k) database record so you can verify and read the summary.
Who should care
A short note on which buyers, suppliers or partners each clearance is most relevant to.
Delivered by email
Monthly PDF digest on every plan; Pro and Team add the full CSV spreadsheet and more.
02 Who it's for
Built for people who sell to, build for, or invest in medtech.
Medtech sales reps
Find newly cleared devices and the companies behind them in your territory and specialty.
Distributors
Spot new products, especially from overseas manufacturers, that may need US distribution.
Contract manufacturers
See which companies just cleared devices and may be scaling production.
Regulatory consultants
Track product codes and predicate activity in the areas where you advise clients.
Investors
Follow clearance activity by company and specialty as a signal of commercial progress.
03 Sample preview
Real rows from the sample issue.
Download the free sample PDF ↓The six most recent of 278 clearances decided Sep 12 – Oct 11, 2026. The full sample is a 28-page PDF digest grouped by specialty.
| Decision | K number | Device | Code | Panel | Applicant | Country |
|---|---|---|---|---|---|---|
| 2026-10-11 | K253717 | Helo™ Return | CAC | Anesthesiology | Endovascular Engineering, Inc. | US |
| 2026-10-09 | K262068 | Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) | DRF | Cardiovascular | CathRx, Ltd. | AU |
| 2026-10-09 | K261649 | Excelsior Reach Microcatheter | QJP | Cardiovascular | Stryker Neurovascular | US |
| 2026-10-09 | K260687 | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChe… | NBW | Clinical Chemistry | Vivachek Biotech (Hangzhou) Co., Ltd. | CN |
| 2026-10-09 | K260096 | Wishbone HAE | NPM | Dental | Wishbone SA | BE |
| 2026-10-09 | K260913 | CMF Titanium Splints | DZJ | Dental | Materialise NV | BE |
Source: openFDA device 510(k) endpoint. Scroll the table sideways on small screens.
04 Pricing
Simple monthly plans. Cancel anytime.
Digest
$29/mo
The monthly report, ready to read.
- Monthly PDF digest
- Clearances grouped by specialty
- Links to every FDA record
- Delivered by email
Pro
$99/mo
The data you can work with.
- Everything in Digest
- Full spreadsheet (CSV) every month
- Alerts for your chosen specialties and product codes
- Company websites
Team
$249/mo
For teams that live in the data.
- Everything in Pro
- Full clearance history
- Google Sheets sync
- Multiple users
Secure checkout by Stripe. Prices in USD, billed monthly.
05 FAQ
Questions
Where does the data come from?
From the U.S. FDA's public openFDA device 510(k) dataset. We organize, group and annotate it; every row links back to the official FDA record so you can verify it.
How is the report delivered?
By email each month. Digest subscribers get the PDF; Pro and Team subscribers also get the CSV spreadsheet.
Can I cancel anytime?
Yes. Subscriptions are billed monthly through Stripe and you can cancel at any time. You keep access through the end of the period you paid for.
What period does each issue cover?
Roughly one month of FDA decision dates. The free sample covers clearances decided Sep 12 to Oct 11, 2026.
Is this regulatory or investment advice?
No. It's an organized summary of public FDA data for research and prospecting. Always confirm details against the FDA record.