# K920413: Decomat a 8666

- Pathway: 510(k) (Traditional)
- Applicant: Getinge International, Inc.
- Decided: Apr 5, 1994 after 795 days
- Product code: MDZ (Cleaners, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6992
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Mar 25, 2003 · Not classified · Z-0908-03: Hot water may splash from the washer chamber creating a burn hazard.

Source page: https://510kreport.com/device/K920413
Methodology: https://510kreport.com/methodology