FDA product code FKP: System, Dialysate Delivery, Single Patient
FKP is the FDA product code for system, dialysate delivery, single patient. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 50 510(k) submissions under FKP, from 23 different applicants. The average 510(k) review took 141 days (median 72). FDA has posted 12 recalls for FKP devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Dialysate Delivery, Single Patient |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for FKP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 62 |
Compare with all 510(k) review times · Search every FKP clearance
Top FKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gambro, Inc. | 6 | 1990-09-28 |
| Nxstage Medical, Inc. | 4 | 2018-09-26 |
| Fresenius USA, Inc. | 4 | 1996-06-13 |
| Cobe Laboratories, Inc. | 4 | 1991-02-12 |
| Extracorporeal Medical Specialities, Inc. | 4 | 1981-11-16 |
18 more applicants have FKP clearances. See the full list in Caduvo.
Most recent FKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181991 | Nxstage Medical, Inc. | NxStage Connected Health System | 2018-09-26 | 62 |
| K131739 | Nxstage Medical, Inc. | NXSTAGE CONNECTED HEALTH SYSTEM | 2013-10-10 | 119 |
| K130460 | Nxstage Medical, Inc. | NXSTAGE DOSING CALCULATOR | 2013-07-11 | 139 |
| K040074 | Nxstage Medical, Inc. | ONEVIEW INTERFACE | 2004-04-08 | 85 |
| K021060 | Fresenius Medical Care North America | FRESENIUS ICARE MONITORING SYSTEM | 2002-11-13 | 225 |
Recalls for FKP devices
12 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-01-29.
Frequently asked questions
What is FDA product code FKP?
FKP is the FDA product code for system, dialysate delivery, single patient. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKP?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKP?
Across 50 cleared submissions the average was 141 days from receipt to decision (median 72).
Which companies have the most FKP clearances?
Gambro, Inc. (6); Nxstage Medical, Inc. (4); Fresenius USA, Inc. (4); Cobe Laboratories, Inc. (4); Extracorporeal Medical Specialities, Inc. (4).
Have FKP devices been recalled?
Yes: 12 product recalls across 7 recall events; the most recent began 2010-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FKP
- Run a recall and safety report across every FKP manufacturer
- Watch product code FKP 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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