Container, Transport, Kidney
A kidney transport container is a specialized device used to preserve and transport harvested donor kidneys from the procurement site to the transplant center under controlled conditions that maintain organ viability. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. Product code KDK is regulated under 21 CFR 876.5880 in the Gastroenterology, Urology medical specialty. This device is eligible for third-party review under FDA's accredited persons program.
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Basic Information
- Product Code
- KDK
- Device Class
- FDA class 2
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K053169 | RM3 RENAL PRESERVATION SYSTEM | Jan 17, 2006 | Substantially Equivalent | Waters Instruments, Inc. |
| K911577 | HYPOTRANS MODEL 750 | Jul 08, 1992 | Substantially Equivalent | Martin Mclane Medical |
| K801899 | KEITHLEY LYMPHOCYTE DEPLETION CART | Sep 26, 1980 | Substantially Equivalent | Keithley Development Co. |