# K972193: Olympix Mini-Pasteurmatic (58210)

- Pathway: 510(k) (Traditional)
- Applicant: Olympic Medical Corp.
- Decided: Sep 5, 1997 after 87 days
- Product code: LDS (Device, Pasteurization, Hot Water)
- Device class: 2
- Regulation: 21 CFR 880.6991
- 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) Olympic Pasteurmatic: named in the summary without a submission number

## Indications for use
Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers.

Source page: https://510kreport.com/device/K972193
Methodology: https://510kreport.com/methodology