FDA product code NFK: Kit, Repair, Catheter, Hemodialysis
NFK is the FDA product code for kit, repair, catheter, hemodialysis. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 11 510(k) submissions under NFK, from 6 different applicants. The average 510(k) review took 77 days (median 85). FDA has posted 12 recalls for NFK devices.
Definition
Hemodialysis Tray
Classification
| Field | Value |
|---|---|
| Device name | Kit, Repair, Catheter, Hemodialysis |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| 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 NFK clearance
Top NFK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 5 | 2010-07-29 |
| Spire Biomedical, Inc. | 2 | 2006-12-05 |
| Kendall | 1 | 2009-11-19 |
| Medcomp | 1 | 2002-10-31 |
| Diatek, Inc. | 1 | 2002-05-09 |
1 more applicants have NFK clearances. See the full list in Caduvo.
Most recent NFK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101261 | C.R. Bard, Inc. | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | 2010-07-29 | 85 |
| K092797 | Kendall | ACUTE AND CHRONIC CATHETER REPAIR KIT | 2009-11-19 | 69 |
| K063446 | C.R. Bard, Inc. | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | 2006-12-15 | 30 |
| K062435 | Spire Biomedical, Inc. | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS | 2006-12-05 | 106 |
| K030442 | C.R. Bard, Inc. | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | 2003-07-21 | 160 |
Recalls for NFK devices
12 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-07-06.
| Year | Recalls |
|---|---|
| 2018 | 10 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code NFK?
NFK is the FDA product code for kit, repair, catheter, hemodialysis. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is NFK?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFK?
Across 11 cleared submissions the average was 77 days from receipt to decision (median 85).
Which companies have the most NFK clearances?
C.R. Bard, Inc. (5); Spire Biomedical, Inc. (2); Kendall (1); Medcomp (1); Diatek, Inc. (1).
Have NFK devices been recalled?
Yes: 12 product recalls across 2 recall events; the most recent began 2020-07-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NFK
- Run a recall and safety report across every NFK manufacturer
- Watch product code NFK 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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