FDA product code FKD: Canister, Coil
FKD is the FDA product code for canister, coil. 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 FKD. The average 510(k) review took 64 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Canister, Coil |
| 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 FKD clearance
Top FKD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Estracorporeal, Inc. | 1 | 1979-05-02 |
Most recent FKD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790382 | Estracorporeal, Inc. | COIL DIALYSIS, MODELS DM-360 AND DM-360- | 1979-05-02 | 64 |
Recalls for FKD devices
openFDA lists no recalls for product code FKD.
Frequently asked questions
What is FDA product code FKD?
FKD is the FDA product code for canister, coil. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKD?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKD?
Across 1 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most FKD clearances?
Estracorporeal, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKD
- Run a recall and safety report across every FKD manufacturer
- Watch product code FKD 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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