FDA product code FKN: Adaptor, Shunt
FKN is the FDA product code for adaptor, shunt. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FKN, from 2 different applicants. The average 510(k) review took 58 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Shunt |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every FKN clearance
Top FKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akcess Medical Products, Inc. | 2 | 1989-06-08 |
| Quinton, Inc. | 2 | 1981-12-31 |
Most recent FKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893478 | Akcess Medical Products, Inc. | DA-16 AND DA-24 SHUNT ADAPTERS | 1989-06-08 | 35 |
| K892667 | Akcess Medical Products, Inc. | SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 | 1989-05-04 | 21 |
| K813428 | Quinton, Inc. | SHUNT ADAPTER | 1981-12-31 | 23 |
| K771425 | Quinton, Inc. | A-V SHUNT EXTENSION | 1978-01-03 | 155 |
Recalls for FKN devices
openFDA lists no recalls for product code FKN.
Frequently asked questions
What is FDA product code FKN?
FKN is the FDA product code for adaptor, shunt. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FKN?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKN?
Across 4 cleared submissions the average was 58 days from receipt to decision (median 29).
Which companies have the most FKN clearances?
Akcess Medical Products, Inc. (2); Quinton, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FKN
- Run a recall and safety report across every FKN manufacturer
- Watch product code FKN 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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