# K142034: 3M Steri-Vac Sterilizer/Aerator

- Pathway: 510(k) (Abbreviated)
- Applicant: 3M Company
- Decided: Jan 8, 2015 after 164 days
- Product code: FLF (Sterilizer, Ethylene-Oxide Gas)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941748 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941748: Steri-Vac Gas Sterilizer Model 8XL, 3M Health Care, Ltd. (1994) Summary page 4.

## Indications for use
The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles: Model Cycle Gas Expose Time (min.) Temperature (deg C) EO Concentration (mg/L) Relative Humidity (%)* GS5 Cool 270 38 736 40-80 Warm 60 55 736 40-80 GS8 Cool 270 38 759 40-80 Warm 60 55 759 40-80 Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instrument’s sterilization instructions. The load per cycle should not exceed 20 lumens.

Source page: https://510kreport.com/device/K142034
Methodology: https://510kreport.com/methodology