FDA product code FKL: Insert, Pump, Blood
FKL is the FDA product code for insert, pump, blood. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FKL. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Insert, Pump, Blood |
| 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 FKL clearance
Top FKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Organon Teknika Corp. | 1 | 1985-11-08 |
Most recent FKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854084 | Organon Teknika Corp. | PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT | 1985-11-08 | 32 |
Recalls for FKL devices
openFDA lists no recalls for product code FKL.
Frequently asked questions
What is FDA product code FKL?
FKL is the FDA product code for insert, pump, blood. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKL?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKL?
Across 1 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most FKL clearances?
Organon Teknika Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKL
- Run a recall and safety report across every FKL manufacturer
- Watch product code FKL 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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