# K261055: AMSCO 700 Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jun 24, 2026 after 85 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: 1 generation back to K232485 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232485: AMSCO 600 Steam Sterilizer, Steris (2023) Summary page 7.

## Indications for use
The AMSCO 700 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. AMSCO 700 Steam Sterilizer sterilization cycles and cycle values Sterilize Cycles Sterilize Time Dry Time Maximum Recommended Load Temperature Fabric Packs. Refer to Table 2 for Prevac 270°F (132°C) 4 minutes 20 minutes recommended quantities. Double wrapped instrument trays, maximum Prevac 270°F (132°C) 4 minutes 30 minutes weight 25 lbs. (11.3 kg) each and Fabric Packs. See Table 2 for maximum quantities. Prevac 270°F (132°C) 4 minutes 5 minutes Single Fabric Pack. Double wrapped instrument trays, maximum Prevac 275°F (135°C) 3 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2 for recommended quantities. Double wrapped instrument trays, maximum Prevac 270°F (132°C) 10 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2 for recommended quantities. Prevac- 270°F (132°C) 4 minutes 1 minute Immediate use – single unwrapped tray IUSS Double wrapped instrument trays, maximum Gravity 270°F (132°C) 15 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2 for recommended quantities. Double wrapped instrument trays, maximum Gravity 250°F (121°C) 30 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2 for recommended quantities. Warm-Up 270°F (132°C) 3 minutes 1 minute N/A DART 270°F (132°C) 3.5 minutes 1 minute Bowie-Dick Test Pack, DART Test Pack Leak Test N/A N/A N/A N/A The maximum quantities of wrapped instrument trays or fabric packs for each proposed model are as follows: Table 2. AMSCO 700 Steam Sterilizer maximum load per sterilizer size Wrapped Sterilizer Size Fabric Packs Instrument Trays 26” x 26” x 39” 9 12 26” x 26” x 51” 12 16 26” x 26” x 63” 15 20 The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 700 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/K261055
Methodology: https://510kreport.com/methodology