# K220736: Consolidated HC Steam Sterilizer

- Pathway: 510(k) (Abbreviated)
- Applicant: Consolidated Machine Corp.
- Decided: Aug 1, 2022 after 140 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183410: AMSCO 600 Steam Sterilizer, STERIS Corporation (2019) Summary page 7.

## Indications for use
The Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 R2018 for all models of the HC Series steam sterilizers are provided below. Table 1: Validated Sterilization Cycles Cycle Type | Sterilization Temperature | Sterilization Time | Dry Time | Load Type Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Fabric Packs Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg) Gravity – IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped Tray Maximum weight per tray: 25lbs (11.3 kg) Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg) Pre-Vacuum – IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped Tray Maximum weight per tray: 25lbs (11.3 kg) Pre-Vacuum | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs Pre-Vacuum | 270°F (132°C) | 4 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg) Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg) Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and Single Unwrapped Tray Maximum weight per tray: 25lbs (11.3 kg) Liquids | 250°F (121°C) | 30 minutes | N/A | 1L Liquid Volumes Bowie Dick Test | 273°F (134°C) | 3.5 minutes | 0 minutes | Bowie Dick Test Pack Vacuum Leak Test | 270°F (132°C) | N/A | N/A | Empty Chamber Warm Up | 270°F (132°C) | 3 minutes | 1 minutes | Empty Chamber Table 2: Load Size Model | Sterilizer Chamber Size | Double Wrapped Instrument Trays | Fabric Packs2 | Number of Liquid Containers3 26AV-HC | 26” X 26” X 39” | 9, maximum weight 25lb each | 12 | 70, 1 Liter Volume Per Container 26BV-HC | 26” X 26” X 49” | 12, maximum weight 25lb each | 16 | 90, 1 Liter Volume Per Container 3AV-HC | 20” X 20” X 38” | 3, maximum weight 25lb each | 9 | 28, 1 Liter Volume Per Container 1 For instrument trays, the maximum weight per tray is 25lbs (11.3 kg). 2 The weight of each fabric pack should be limited to approximately 3.2 lbs (1.4 kg) with a density of 11.3 lb/ft3 (181 kg/m3) or less. 3 For liquid containers, the maximum volume of liquid per container is 1,000 ml. Please note, liquid loads processed in the sterilizer are inappropriate for direct patient contact.

Source page: https://510kreport.com/device/K220736
Methodology: https://510kreport.com/methodology