FDA product code FKO: Catheter, Peritoneal Dialysis, Single Use
FKO is the FDA product code for catheter, peritoneal dialysis, single use. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 16 510(k) submissions under FKO, from 12 different applicants. The average 510(k) review took 125 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Peritoneal Dialysis, Single Use |
| Device class | Class II |
| Regulation | 21 CFR 876.5630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FKO clearance
Top FKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 5 | 1987-12-09 |
| Corpak, Inc. | 1 | 1998-06-26 |
| Medigroup, Inc. | 1 | 1998-02-27 |
| Accurate Surgical Instruments Co. | 1 | 1991-08-15 |
| Bernard J. Cooney, P.A. | 1 | 1990-10-19 |
7 more applicants have FKO clearances. See the full list in Caduvo.
Most recent FKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964514 | Corpak, Inc. | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | 1998-06-26 | 605 |
| K974570 | Medigroup, Inc. | PERITONEAL DIALYSIS CATHETER CONNECTOR | 1998-02-27 | 81 |
| K910787 | Accurate Surgical Instruments Co. | TITANIUM CONNECTOR (2 PART) | 1991-08-15 | 171 |
| K885037 | Bernard J. Cooney, P.A. | AMUKIN 50% - AIRSPRAY(R) | 1990-10-19 | 683 |
| K874650 | Quinton, Inc. | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | 1987-12-09 | 26 |
Recalls for FKO devices
openFDA lists no recalls for product code FKO.
Frequently asked questions
What is FDA product code FKO?
FKO is the FDA product code for catheter, peritoneal dialysis, single use. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is FKO?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKO?
Across 16 cleared submissions the average was 125 days from receipt to decision (median 33).
Which companies have the most FKO clearances?
Quinton, Inc. (5); Corpak, Inc. (1); Medigroup, Inc. (1); Accurate Surgical Instruments Co. (1); Bernard J. Cooney, P.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKO
- Run a recall and safety report across every FKO manufacturer
- Watch product code FKO 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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