# K941748: Steri-Vac Gas Sterilizer Model 8XL

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Ltd.
- Decided: Dec 2, 1994 after 238 days
- Product code: FLF (Sterilizer, Ethylene-Oxide Gas)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K142034: 3M Steri-Vac Sterilizer/Aerator (2015), 0 descendants of its own

## Recalls of this device
- Jan 22, 2016 · Class II · Z-1563-2016: 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failur
- Mar 17, 2014 · Class II · Z-1318-2014: Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation invol
- Sep 13, 2012 · Class II · Z-0022-2013: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is 

Source page: https://510kreport.com/device/K941748
Methodology: https://510kreport.com/methodology