FDA product code FLA: Monitor, Temperature, Dialysis
FLA is the FDA product code for monitor, temperature, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FLA, from 3 different applicants. The average 510(k) review took 64 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Temperature, Dialysis |
| 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 FLA clearance
Top FLA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nxstage Medical, Inc. | 1 | 2014-06-16 |
| Organon Teknika Corp. | 1 | 1984-08-27 |
| Laminar Flow Industries | 1 | 1981-01-23 |
Most recent FLA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140623 | Nxstage Medical, Inc. | NXSTAGE EXPRESS FLUID WARMER | 2014-06-16 | 97 |
| K842302 | Organon Teknika Corp. | FLUID WARMER | 1984-08-27 | 77 |
| K810021 | Laminar Flow Industries | FLO-TEMP | 1981-01-23 | 18 |
Recalls for FLA devices
openFDA lists no recalls for product code FLA.
Frequently asked questions
What is FDA product code FLA?
FLA is the FDA product code for monitor, temperature, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FLA?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLA?
Across 3 cleared submissions the average was 64 days from receipt to decision (median 77).
Which companies have the most FLA clearances?
Nxstage Medical, Inc. (1); Organon Teknika Corp. (1); Laminar Flow Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FLA
- Run a recall and safety report across every FLA manufacturer
- Watch product code FLA 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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