# K070657: Getinge 633HC Series Vacuum/Gravity Steam Sterilizer

- Pathway: 510(k) (Special)
- Applicant: Getinge Sourcing, LLC
- Decided: Apr 5, 2007 after 27 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: 4 generations back to K820783 (1982). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC, Getinge/Castle, Inc. (2001) Summary page 3.

## Most influential descendants
- K172159: Getinge GSS67N Series Steam Sterilizer (2018), 3 descendants of its own
- K201927: Getinge GSS610N Series Steam Sterilizer (2021), 1 descendant of its own
- K252307: Getinge GSS67N Series Steam Sterilizer (2026), 0 descendants of its own
- K214120: GSS610N21 Series Steam Sterilizer (2022), 0 descendants of its own
- K120532: Getinge 633HC Steam Sterilizer Air Glide System (2013), 0 descendants of its own

## Indications for use
The Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and 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/K070657
Methodology: https://510kreport.com/methodology