# K091136: Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Jun 29, 2009 after 70 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010865 (2001). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 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.

## Most influential descendants
- K173481: Amsco Evolution Medium Steam Sterilizer (2018), 1 descendant of its own
- K092490: Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000 (2009), 1 descendant of its own
- 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
- K173493: Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 (2018), 0 descendants of its own

## Recalls of this device
- Dec 26, 2018 · Class II · Z-0824-2019: The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falli
- Oct 18, 2013 · Class II · Z-0478-2014: The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
- Mar 23, 2012 · Not classified · Z-1522-2012: Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer ca

## Indications for use
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 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 4-1): Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values 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 4-3 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 4-3 for recommended quantities. Liquid 250°F (121°C) 45 minutes N/A Refer to Table 4-4 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 4-3 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 4-3 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 4-3 for recommended quantities. Gravity 270°F (132°C) 25 minutes 15 minutes Fabric Packs. Refer to Table 4-3 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 4-2): Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse(SFPP) Sterilizer factory-programmed sterilization cycles and cycle values 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 4-3 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 4-3 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 4-3 for recommended quantities. Gravity 250°F (121°C) 30 minutes 15 minutes Fabric Packs. Refer to Table 4-3 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 4-3 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 4-3 for recommended quantities. Liquid 250°F (121°C) 45 minutes N/A Refer to Table 4-4 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 4-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size 26" x 37 ½" x 42" 12 18 26" x 37 ½" x 54" 16 30 The following table is a guideline for liquid cycle processing: Table 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle* Guideline 3 1000 ml 45 minutes *The liquid cycle is for non-patient contact use only. The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes: * 26" x 37½" x 42" (Model HC - 900) * 26" x 37½" x 54" (Model HC-1200)

Source page: https://510kreport.com/device/K091136
Methodology: https://510kreport.com/methodology