FDA product code KDK: Container, Transport, Kidney
KDK is the FDA product code for container, transport, kidney. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under KDK, from 3 different applicants. The average 510(k) review took 190 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Container, Transport, Kidney |
| Device class | Class II |
| Regulation | 21 CFR 876.5880 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KDK clearance
Top KDK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Waters Instruments, Inc. | 1 | 2006-01-17 |
| Martin Mclane Medical | 1 | 1992-07-08 |
| Keithley Development Co. | 1 | 1980-09-26 |
Most recent KDK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053169 | Waters Instruments, Inc. | RM3 RENAL PRESERVATION SYSTEM | 2006-01-17 | 64 |
| K911577 | Martin Mclane Medical | HYPOTRANS MODEL 750 | 1992-07-08 | 457 |
| K801899 | Keithley Development Co. | KEITHLEY LYMPHOCYTE DEPLETION CART | 1980-09-26 | 49 |
Recalls for KDK devices
openFDA lists no recalls for product code KDK.
Frequently asked questions
What is FDA product code KDK?
KDK is the FDA product code for container, transport, kidney. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel.
What device class is KDK?
Class II, regulation 21 CFR 876.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code KDK?
Across 3 cleared submissions the average was 190 days from receipt to decision (median 64).
Which companies have the most KDK clearances?
Waters Instruments, Inc. (1); Martin Mclane Medical (1); Keithley Development Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KDK
- Run a recall and safety report across every KDK manufacturer
- Watch product code KDK 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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