# K081094: Olympic Pasteurmatic, Models 3000 and 3500

- Pathway: 510(k) (Special)
- Applicant: Olympic Medical Corp.
- Decided: Jun 20, 2008 after 64 days
- Product code: MEC (Disinfector, 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
Longest line of descent: 1 generation back to K953645 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953645: Olympic Pasteurmatic System, Olympic Medical Corp. (1995) Summary page 1.

## Recalls of this device
- May 22, 2017 · Class II · Z-2701-2017: Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the 

## Indications for use
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disirfection of respiratory therapy and anesthesia equipment in a hot water bath at 160 ° 170 ° F for 30 minutes.

Source page: https://510kreport.com/device/K081094
Methodology: https://510kreport.com/methodology