FDA product code FKA: Dilator, Vessel
FKA is the FDA product code for dilator, vessel. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FKA, from 3 different applicants. The average 510(k) review took 266 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Vessel |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FKA clearance
Top FKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spire Biomedical, Inc. | 1 | 2002-10-11 |
| Vas-Cath, Inc. | 1 | 1993-07-01 |
| Akcess Medical Products, Inc. | 1 | 1991-04-29 |
Most recent FKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022620 | Spire Biomedical, Inc. | SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT | 2002-10-11 | 65 |
| K914210 | Vas-Cath, Inc. | VAS-CATH DUALATOR(TM) VESSEL DILATOR | 1993-07-01 | 651 |
| K910502 | Akcess Medical Products, Inc. | VESSEL DILATORS | 1991-04-29 | 83 |
Recalls for FKA devices
openFDA lists no recalls for product code FKA.
Frequently asked questions
What is FDA product code FKA?
FKA is the FDA product code for dilator, vessel. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FKA?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKA?
Across 3 cleared submissions the average was 266 days from receipt to decision (median 83).
Which companies have the most FKA clearances?
Spire Biomedical, Inc. (1); Vas-Cath, Inc. (1); Akcess Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKA
- Run a recall and safety report across every FKA manufacturer
- Watch product code FKA 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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