# K173493: Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 23, 2018 after 102 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: 5 generations back to K010865 (2001). 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)
- K092490: Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000, STERIS Corporation (2009) Summary page 8.

## Indications for use
The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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 Series Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1): Table 5-1. Amsco Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values Cycles Sterilize Sterilize Dry Time Recommended Load Temperature Time Prevac 270°F (132°C) 4 minutes 30 minutes | Double wrapped instrument trays, maximum weight 25 Ibs (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 Ibs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Gravity 270°F (132°C) 15 minutes | 45 minutes | Double wrapped instrument trays, maximum weight 25 Ibs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. Gravity 250°F (121°C) 30 minutes | 45 minutes | Double wrapped instrument trays, maximum weight 25 Ibs (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 270°F (132°C) 3 minutes 1 minute N/A Warm-Up 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 Series 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 Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values Cycles Sterilize Sterilize Dry Time Recommended Load Temperature Time SFPP 270°F (132°C) 4 minutes 45 minutes | Double wrapped instrument trays, maximum weight 25 Ibs (11.3 kg) each and Fabric Packs. Refer to Table 5-3 for recommended quantities. SFPP 275°F (135°C) 3 minutes 45 minutes | Double wrapped instrument trays, maximum weight 25 Ibs (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 Ibs (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 Ibs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. Gravity 270°F (132°C) 15 minutes | 45 minutes | Double wrapped instrument trays, maximum weight 25 Ibs (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 270°F (132°C) 3 minutes 1 minute N/A Warm-Up 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 Series Steam Sterilizer recommended loads per sterilizer size Sterilizer Size Wrapped Instrument Trays Fabric Packs 26” x 61” x 49” HC-2000 15 40 26” x 61” x 72” HC-3000 25 60 The following table is a guideline for liquid cycle processing: Table 5-4. Amsco Evolution Series 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 Series Steam Sterilizer is offered in the following chamber sizes: • Model HC - 2000 26” x 61” x 49” • Model HC - 3000 26” x 61” x 72”

Source page: https://510kreport.com/device/K173493
Methodology: https://510kreport.com/methodology