# K960169: Carbomedics Valve Tester

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Apr 15, 1996 after 90 days
- Product code: DTJ (Holder, Heart-Valve, Prosthesis)
- Device class: 1
- Regulation: 21 CFR 870.3935
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 30, 2002 · Not classified · Z-0738-04: Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.

Source page: https://510kreport.com/device/K960169
Methodology: https://510kreport.com/methodology