# K936181: Midmark M-11 Ultraclave Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corp.
- Decided: Nov 30, 1994 after 338 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- 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.
20 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer (1999), 19 descendants of its own
- K023348: Midmark M9 Ultraclave Steam Sterilizer (2003), 13 descendants of its own
- K050263: Millennium Series, Including Millennium B, B+, B2 and BU (2006), 8 descendants of its own
- K143311: Pre-vacuum Tabletop Autoclave (2015), 6 descendants of its own
- K213080: T-Edge 10, T-Edge 11 (2022), 2 descendants of its own

## Recalls of this device
- Oct 24, 2011 · Not classified · Z-0597-2012: During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.

Source page: https://510kreport.com/device/K936181
Methodology: https://510kreport.com/methodology