# K041833: Consolidated SR and Sse MC-Series Steam Sterilizer

- Pathway: 510(k) (Abbreviated)
- Applicant: Consolidated Machine Corp.
- Decided: Dec 10, 2004 after 156 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K820783 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994314: Castle Series 100HC Steam Sterilizers, Getinge/Castle, Inc. (2000) Summary page 1.

## Indications for use
Consolidated SSR and SR MC-Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

Source page: https://510kreport.com/device/K041833
Methodology: https://510kreport.com/methodology