# K812867: Steri-Vac #400C Gas Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Nov 2, 1981 after 20 days
- Product code: FLF (Sterilizer, Ethylene-Oxide Gas)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K150646: EOGas 4 Ethylene Oxide Gas Sterilizer (2015), 2 descendants of its own
- K192978: EOGas 4 Ethylene Oxide Gas Sterilizer (2020), 0 descendants of its own
- K170432: Anprolene AN75 Ethylene Oxide Gas Sterilizer (2017), 0 descendants of its own

## Recalls of this device
- 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

Source page: https://510kreport.com/device/K812867
Methodology: https://510kreport.com/methodology