FDA product code FLC: Station, Dialysis Control, Negative Pressure Type
FLC is the FDA product code for station, dialysis control, negative pressure type. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FLC, from 4 different applicants. The average 510(k) review took 60 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Station, Dialysis Control, Negative Pressure Type |
| 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 FLC clearance
Top FLC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 1 | 1991-04-25 |
| Seratronics, Inc. | 1 | 1986-01-21 |
| Medicorp, Inc. | 1 | 1979-10-04 |
| Gambro, Inc. | 1 | 1976-10-27 |
Most recent FLC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910656 | Wilson-Cook Medical, Inc. | WILSON-COOK DISPOSABLE BIOPSY FORCEPS | 1991-04-25 | 70 |
| K855001 | Seratronics, Inc. | FRESENIUS HEMODIALYSIS MACHINE A1008 BSM | 1986-01-21 | 39 |
| K791164 | Medicorp, Inc. | NEGATOVE PRESSURE CONVERTOR | 1979-10-04 | 101 |
| K760725 | Gambro, Inc. | COIL MACHINE ADAPTER | 1976-10-27 | 30 |
Recalls for FLC devices
openFDA lists no recalls for product code FLC.
Frequently asked questions
What is FDA product code FLC?
FLC is the FDA product code for station, dialysis control, negative pressure type. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FLC?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLC?
Across 4 cleared submissions the average was 60 days from receipt to decision (median 54).
Which companies have the most FLC clearances?
Wilson-Cook Medical, Inc. (1); Seratronics, Inc. (1); Medicorp, Inc. (1); Gambro, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FLC
- Run a recall and safety report across every FLC manufacturer
- Watch product code FLC 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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