FDA product code FKI: Set, Dialyzer Holder
FKI is the FDA product code for set, dialyzer holder. 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 FKI, from 3 different applicants. The average 510(k) review took 28 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Set, Dialyzer Holder |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FKI clearance
Top FKI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bentley | 1 | 1984-10-18 |
| Extracorporeal Medical Specialities, Inc. | 1 | 1981-06-02 |
| Renal Devices, Inc. | 1 | 1980-09-16 |
Most recent FKI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843504 | American Bentley | AMER. BENTLEY HEMOFILTER HOLDER HFH-1 | 1984-10-18 | 42 |
| K811292 | Extracorporeal Medical Specialities, Inc. | PARALLEL PLATE DIALYZER HOLDER | 1981-06-02 | 22 |
| K802075 | Renal Devices, Inc. | HOLLOW FIBER DIALYZER HOLDER | 1980-09-16 | 20 |
Recalls for FKI devices
openFDA lists no recalls for product code FKI.
Frequently asked questions
What is FDA product code FKI?
FKI is the FDA product code for set, dialyzer holder. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKI?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FKI?
Across 3 cleared submissions the average was 28 days from receipt to decision (median 22).
Which companies have the most FKI clearances?
American Bentley (1); Extracorporeal Medical Specialities, Inc. (1); Renal Devices, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKI
- Run a recall and safety report across every FKI manufacturer
- Watch product code FKI 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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