FDA product code LYK: Angioscope
LYK is the FDA product code for angioscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Cardiovascular panel. FDA has cleared 41 510(k) submissions under LYK, 2 in the last five years, from 24 different applicants. The average 510(k) review took 155 days (median 133); 85 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Angioscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for LYK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 113 |
| 2026 | 1 | 57 |
Compare with all 510(k) review times · Search every LYK clearance
Top LYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Resources | 3 | 1995-07-11 |
| Intertherapy, Inc. | 3 | 1991-11-20 |
| American Edwards Laboratories | 3 | 1984-10-18 |
| Vena Medical Holdings Corp | 2 | 2026-01-28 |
| Cardio-Optics, Inc. | 2 | 2006-11-30 |
19 more applicants have LYK clearances. See the full list in Caduvo.
Most recent LYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253842 | Vena Medical Holdings Corp | Vena MicroAngioscope System | 2026-01-28 | 57 |
| K251767 | Vena Medical Holdings Corp | Vena MicroAngioscope System | 2025-10-01 | 113 |
| K062340 | Cardio-Optics, Inc. | CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM | 2006-11-30 | 112 |
| K050808 | Cardio-Optics, Inc. | CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 | 2005-07-28 | 120 |
| K011793 | KARL STORZ Endoscopy-America, Inc. | KSEA FIBERSCOPE | 2002-04-17 | 313 |
Recalls for LYK devices
openFDA lists no recalls for product code LYK.
Frequently asked questions
What is FDA product code LYK?
LYK is the FDA product code for angioscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Cardiovascular panel.
What device class is LYK?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYK?
Across 41 cleared submissions the average was 155 days from receipt to decision (median 133).
Which companies have the most LYK clearances?
Applied Medical Resources (3); Intertherapy, Inc. (3); American Edwards Laboratories (3); Vena Medical Holdings Corp (2); Cardio-Optics, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LYK
- Run a recall and safety report across every LYK manufacturer
- Watch product code LYK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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