# K092490: Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Nov 4, 2009 after 83 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)
- K082435: Amsco Evolution Medium Steam Sterilizer, STERIS Corporation (2008) Summary page 2.
- K091136: Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200, STERIS Corporation (2009) Summary page 2.

## Most influential descendants
- K173493: Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 (2018), 0 descendants of its own

## 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 4-1): Table 4-1. Amsco Evolution Series Prevacuum Steam Sterilizer factor -rorammed sterilization cycles and ycle values Prevac 270° (132°C) 4 minutes 30 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. Prevac 2700 F (132°C) 4 minutes 5 minutes Single Fabric Pack Gravity 250°F (121°C) 30 minutes 15 minutes Fabric Packs. Refer to Table 4-3 for recommended quantities. Liquid* 250W (121 0 C) 45 minutes N/A Refer to Table 4-4for recommended quantities. Prevac 275F (135°C) 3 minutes 30 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities. "гиCycles~ sPa~ ~~~ ie~4%?fii~f~4•W mmtS~iie, Gravity 270F (132°C) 15 minutes 45 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities. Gravity 250°F (121°C) 30 minutes 45 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities. Gravity 270°F (132 0 C) 25 minutes 15 minutes Fabric Packs. Refer to Table 4-3 for recommended quantities. DART 270° (132°C) 3 minutes 1 minute N/A Warm-Up DART 270° (132 0 C) 3 ½2 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 4-2): Table 4-2. Amsco Evolution Series Steam Flush Pressure-Pulse(SFPP) Sterilizer factory- ro ammed sterilization c cles and c cle values SFPP 270° (132 0 C) 4 minutes 45 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. SFPP 275° (135°C) 3 minutes 45 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities. Ye Stenhize x~,Vw »s~OStenze 3 .Eny Time; ITm fip~eratureg.________ ,*s 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 4-3for recommended quantities. Gravity 250°F (121°C) 30 minutes 15 minutes Fabric Packs. Refer to Table 4-3for recommended quantities. SFPP 270F (132°C) 4 minutes 5 minutes Single Fabric Pack Prevac 275F (135°C) 3 minutes 30 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities. Gravity 270F (132°C) 15 minutes 45 minutes Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. Liquid* 250° (121°C) 45 minutes N/A Refer to Table 4-4for recommended quantities. DART 270° (132 0 C) 3 minutes 1 minute N/A Warm-Up DART 270F (132 0 C) 3 ½2 minutes 1 minute Bowie-Dick Test Pack, _______I_ 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 4-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size 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 4-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline Kb -Numfber~o4K' R~1~L.... ' 13 L 1000 ml 45 minutes The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes: * ModelHC-2000 26"x61"x49" · Model HGC-3000 26"x61"x72"

Source page: https://510kreport.com/device/K092490
Methodology: https://510kreport.com/methodology