# K031259: Model 833HC Vacuum/Gravity Steam Sterilizer

- Pathway: 510(k) (Special)
- Applicant: Getinge USA, Inc.
- Decided: May 12, 2003 after 21 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: 5 generations back to K820783 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020590: Model 733HC Gravity/Vacuum Steam Sterilizer, Getinge/Castle, Inc. (2002) Summary page 2.

## Indications for use
The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam.

Source page: https://510kreport.com/device/K031259
Methodology: https://510kreport.com/methodology