FDA product code FIF: Set, Dialysis, Single Needle With Uni-Directional Pump
FIF is the FDA product code for set, dialysis, single needle with uni-directional pump. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FIF, from 6 different applicants. The average 510(k) review took 49 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Set, Dialysis, Single Needle With Uni-Directional Pump |
| 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 |
Compare with all 510(k) review times · Search every FIF clearance
Top FIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cd Medical, Inc. | 1 | 1987-10-23 |
| Cobe Laboratories, Inc. | 1 | 1982-03-23 |
| Cardio Med Supplies, Inc. | 1 | 1980-12-22 |
| Medical Components, Inc. | 1 | 1980-09-26 |
| Extracorporeal Medical Specialities, Inc. | 1 | 1979-11-16 |
1 more applicants have FIF clearances. See the full list in Caduvo.
Most recent FIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873279 | Cd Medical, Inc. | 8810 PUMP-PUMP SINGLE NEEDLE DEVICE | 1987-10-23 | 67 |
| K820173 | Cobe Laboratories, Inc. | COBE SINGLE-NEEDLE CONTROLLER #18-756 | 1982-03-23 | 61 |
| K802230 | Cardio Med Supplies, Inc. | BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP | 1980-12-22 | 97 |
| K801967 | Medical Components, Inc. | MEDCOMP FEMORAL VEIN CATHETER | 1980-09-26 | 38 |
| K792174 | Extracorporeal Medical Specialities, Inc. | MODEL DM 353 & DM-353-L SINGLE NEEDLE | 1979-11-16 | 18 |
Recalls for FIF devices
openFDA lists no recalls for product code FIF.
Frequently asked questions
What is FDA product code FIF?
FIF is the FDA product code for set, dialysis, single needle with uni-directional pump. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIF?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIF?
Across 6 cleared submissions the average was 49 days from receipt to decision (median 50).
Which companies have the most FIF clearances?
Cd Medical, Inc. (1); Cobe Laboratories, Inc. (1); Cardio Med Supplies, Inc. (1); Medical Components, Inc. (1); Extracorporeal Medical Specialities, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FIF
- Run a recall and safety report across every FIF manufacturer
- Watch product code FIF 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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