# K211500: AMSCO 600 Medium Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Aug 25, 2021 after 103 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 K010865 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183410: AMSCO 600 Steam Sterilizer, STERIS Corporation (2019) Summary page 6.

## Most influential descendants
- 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
- 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

## 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): Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values Cycles: Prevac, Prevac, Prevac, Prevac, Prevac, Prevac-IUSS, Gravity, Warm-Up, DART, Leak Test. Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size Sterilizer Size: 26” x 26” x 39”, 26” x 26” x 51”, 26” x 26” x 63”. The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

Source page: https://510kreport.com/device/K211500
Methodology: https://510kreport.com/methodology