# K850264: Tuttnauer Pre-Vacuum Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer Co., Ltd.
- Decided: Jun 4, 1985 after 132 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.
13 later devices descend from it; 1 cites it directly.
0 of 14 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
- K063711: Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L Usa SP-2A, 69180 SP-2HA (2007), 12 descendants of its own
- K090783: Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave (2009), 11 descendants of its own
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves (2011), 10 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

Source page: https://510kreport.com/device/K850264
Methodology: https://510kreport.com/methodology