# K980014: The System 2S Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: May 15, 1998 after 133 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The System 2S Steam Sterilizer is designed for efficient, point-of-use sterilization of non-porous and porous, heat and moisture-stabile materials used in outpatient surgery, ambulatory care and urgent care centers. The System 2S Steam Sterilizer is available in one configuration: Prevacuum 16"diameter x 26"length chamber size. The System 2S Steam Sterilizer is equipped with the following factory-programmed set sterilization cycles and cycle values: CYCLES RECOMMENDED LOAD STERILIZE TEMP. STERILIZE TIME DRY TIME FLASH Unwrapped Instrument Tray with single instrument 270°F (132°C) 3 minutes 1 minute GRAVITY* Fabric Pack 250°F (121°C) 30 minutes 15 minutes PREVAC** Double Wrapped Instrument Tray 270°F (132°C) 4 minutes 30 minutes EXPRESS Single Wrapped Instrument Tray with single instrument 270°F (132°C) 4 minutes 3 minutes *250°F Cycle can be adjusted from factory-set value of 15 minutes dry time to 30 minutes dry time for instrument trays. **270°F Cycle can be adjusted from factory-set value of 30 minutes dry time to 5 minutes dry time for single fabric pack.

Source page: https://510kreport.com/device/K980014
Methodology: https://510kreport.com/methodology