FDA product code FKG: Tray, Start/Stop (Including Contents), Dialysis
FKG is the FDA product code for tray, start/stop (including contents), dialysis. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FKG, from 6 different applicants. The average 510(k) review took 209 days (median 80). FDA has posted 11 recalls for FKG devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Start/Stop (Including Contents), Dialysis |
| Device class | Class I |
| 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 FKG clearance
Top FKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J.J. Skinner, Inc. | 1 | 1995-05-03 |
| Dove Medical Supplies | 1 | 1987-05-26 |
| Professional Dialysis Products | 1 | 1984-02-09 |
| Med-Pak Corp. | 1 | 1981-01-16 |
| Cutter Laboratories, Inc. | 1 | 1979-12-10 |
1 more applicants have FKG clearances. See the full list in Caduvo.
Most recent FKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925469 | J.J. Skinner, Inc. | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | 1995-05-03 | 916 |
| K871630 | Dove Medical Supplies | KITS AND TRAYS FOR DIALYSIS USE | 1987-05-26 | 29 |
| K833780 | Professional Dialysis Products | CAPD PREP KIT | 1984-02-09 | 104 |
| K802361 | Med-Pak Corp. | DIALYIS START CARE KIT | 1981-01-16 | 112 |
| K792207 | Cutter Laboratories, Inc. | PERIDIAL PERITONEAL DIALYSIS TRAY | 1979-12-10 | 38 |
Recalls for FKG devices
11 product recalls in 8 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-01-08.
| Year | Recalls |
|---|---|
| 2023 | 4 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FKG?
FKG is the FDA product code for tray, start/stop (including contents), dialysis. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKG?
Class I, regulation 21 CFR 876.5820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FKG?
Across 6 cleared submissions the average was 209 days from receipt to decision (median 80).
Which companies have the most FKG clearances?
J.J. Skinner, Inc. (1); Dove Medical Supplies (1); Professional Dialysis Products (1); Med-Pak Corp. (1); Cutter Laboratories, Inc. (1).
Have FKG devices been recalled?
Yes: 11 product recalls across 8 recall events; the most recent began 2026-01-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FKG
- Run a recall and safety report across every FKG manufacturer
- Watch product code FKG 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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