# K173490: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 22, 2018 after 101 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091731: Amsco Evolution Medium Steam Sterilizer, STERIS Corporation (2009) Summary page 8.

## Most influential descendants
- K203061: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) (2020), 0 descendants of its own

## Indications for use
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations: * Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. * Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1): Table 5-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 5-3 for recommended quantities. Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 5-3 for recommended quantities. Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for recommended quantities. Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 5-3 for recommended quantities. DART Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, DART Test Pack Leak Test | N/A | N/A | N/A | N/A * The liquid cycle is for non-patient contact use only. The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2): Table 5-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 5-3 for recommended quantities. SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 5-3 for recommended quantities. Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 5-3 for recommended quantities. SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for recommended quantities. DART Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, DART Test Pack Leak Test | N/A | N/A | N/A | N/A *The liquid cycle is for non-patient contact use only. The following table lists STERIS’s recommended loads by sterilizer size: Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size Sterilizer Size | Wrapped Instrument Trays | Fabric Packs 26” x 37 ½” x 49” | 12 | 16 26” x 37 ½” x 61” | 15 | 20 The following table is a guideline for liquid cycle processing: Table 5-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle Guideline Number of Containers | Volume of Liquid In One Container | Minimum Recommended Sterilize Time at 250°F (121°C) 3 | 1000 ml | 45 minutes The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes: * 26”x26”x49” (Model HC — 800) * 26”x26”x61” (Model HC — 1000)

Source page: https://510kreport.com/device/K173490
Methodology: https://510kreport.com/methodology