# K920478: Tuttnauer Lsi (Automatic)

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer Co., Ltd.
- Decided: Jul 8, 1993 after 526 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; 2 cite 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993856: Tuttnauer Electronic Autoclave, Models E, EA, EK, Eka, EP (2001), 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
- K232658: T-Top 10 & T-Top T-Top 11 (2023), 1 descendant of its own

Source page: https://510kreport.com/device/K920478
Methodology: https://510kreport.com/methodology