# K990229: Hpa Portable Kidney Preservation System, Model J-1000-1

- Pathway: 510(k) (Traditional)
- Applicant: Justec Medical Products, Inc.
- Decided: Nov 4, 1999 after 283 days
- Product code: KDN (System, Perfusion, Kidney)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MOX-100 Renal Preservation System TM2 Transport Module: named in the summary without a submission number

## Indications for use
The HPA Portable Kidney Preservation System, Model J-1000-1 is to be used when prescribed by a physician for the use of storing and preserving a human kidney

Source page: https://510kreport.com/device/K990229
Methodology: https://510kreport.com/methodology