FDA product code FKK: Clamp, Line
FKK is the FDA product code for clamp, line. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FKK, from 6 different applicants. The average 510(k) review took 49 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Line |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FKK clearance
Top FKK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Travenol Laboratories, S.A. | 1 | 1985-12-02 |
| Rao Medical Devices, Inc. | 1 | 1985-12-02 |
| Dyn-A-Med Products | 1 | 1984-12-17 |
| Delmed, Inc. | 1 | 1983-08-11 |
| American Medical Products, Inc. | 1 | 1982-10-13 |
1 more applicants have FKK clearances. See the full list in Caduvo.
Most recent FKK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854517 | Travenol Laboratories, S.A. | NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET | 1985-12-02 | 20 |
| K854512 | Rao Medical Devices, Inc. | TUBING CLAMP CAT#1000-A | 1985-12-02 | 20 |
| K844121 | Dyn-A-Med Products | CLAMP, TUBING, LINE | 1984-12-17 | 55 |
| K831689 | Delmed, Inc. | EMPTY DIALYSATE CONTAINER | 1983-08-11 | 79 |
| K822551 | American Medical Products, Inc. | AMP CAPD UNISPIKE AMINISTRATION SET | 1982-10-13 | 50 |
Recalls for FKK devices
openFDA lists no recalls for product code FKK.
Frequently asked questions
What is FDA product code FKK?
FKK is the FDA product code for clamp, line. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FKK?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FKK?
Across 6 cleared submissions the average was 49 days from receipt to decision (median 52).
Which companies have the most FKK clearances?
Travenol Laboratories, S.A. (1); Rao Medical Devices, Inc. (1); Dyn-A-Med Products (1); Delmed, Inc. (1); American Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKK
- Run a recall and safety report across every FKK manufacturer
- Watch product code FKK 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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