FDA product code KPF: System, Dialysate Delivery, Semi-Automatic, Peritoneal
KPF is the FDA product code for system, dialysate delivery, semi-automatic, peritoneal. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 13 510(k) submissions under KPF, from 10 different applicants. The average 510(k) review took 172 days (median 101). FDA has posted 5 recalls for KPF devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Dialysate Delivery, Semi-Automatic, Peritoneal |
| 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 KPF clearance
Top KPF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Products, Inc. | 3 | 1980-07-21 |
| Baxter Healthcare Corp | 2 | 2006-09-11 |
| Cybernius Medical , Ltd. | 1 | 1997-07-24 |
| Fresenius USA, Inc. | 1 | 1996-07-31 |
| Denco | 1 | 1994-05-26 |
5 more applicants have KPF clearances. See the full list in Caduvo.
Most recent KPF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061515 | Baxter Healthcare Corp | RENALSOFT | 2006-09-11 | 102 |
| K990953 | Baxter Healthcare Corp | RENAL LINK | 1999-06-18 | 88 |
| K970989 | Cybernius Medical , Ltd. | CYBERREN | 1997-07-24 | 128 |
| K955762 | Fresenius USA, Inc. | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | 1996-07-31 | 226 |
| K913515 | Denco | TOTAL CONTAINMENT DEVICE | 1994-05-26 | 1023 |
Recalls for KPF devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-11-14.
Frequently asked questions
What is FDA product code KPF?
KPF is the FDA product code for system, dialysate delivery, semi-automatic, peritoneal. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is KPF?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPF?
Across 13 cleared submissions the average was 172 days from receipt to decision (median 101).
Which companies have the most KPF clearances?
American Medical Products, Inc. (3); Baxter Healthcare Corp (2); Cybernius Medical , Ltd. (1); Fresenius USA, Inc. (1); Denco (1).
Have KPF devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2007-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KPF
- Run a recall and safety report across every KPF manufacturer
- Watch product code KPF 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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