# K183410: AMSCO 600 Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 27, 2019 after 107 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 K010865 (2001). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112403: Amsco Chimeron Medium Steam Sterlilzer, STERIS Corporation (2012) Summary page 6.

## Most influential descendants
- K211500: AMSCO 600 Medium Steam Sterilizer (2021), 2 descendants of its own
- K222543: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System,  V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (2022), 1 descendant of its own
- K213545: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 (2023), 0 descendants of its own
- K222849: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System,  RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (2022), 0 descendants of its own
- K220736: Consolidated HC Steam Sterilizer (2022), 0 descendants of its own

## Indications for use
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):

Source page: https://510kreport.com/device/K183410
Methodology: https://510kreport.com/methodology