# K120532: Getinge 633HC Steam Sterilizer Air Glide System

- Pathway: 510(k) (Traditional)
- Applicant: Getinge Sourcing, LLC
- Decided: May 2, 2013 after 435 days
- Product code: PEC (Sterilizer Automated Loading System)
- 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)
- K070657: Getinge 633HC Series Vacuum/Gravity Steam Sterilizer, Getinge Sourcing, LLC (2007) Summary page 1.

## Indications for use
The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.

Source page: https://510kreport.com/device/K120532
Methodology: https://510kreport.com/methodology