# K993856: Tuttnauer Electronic Autoclave, Models E, EA, EK, Eka, EP

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer U.S.A Co, Ltd.
- Decided: Feb 9, 2001 after 452 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
Longest line of descent: 1 generation back to K920478 (1993). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920478: Tuttnauer Lsi (Automatic), Tuttnauer Co., Ltd. (1993) Summary page 1.

## Most influential descendants
- 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
- K213457: Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 (2022), 1 descendant of its own

## Indications for use
Tuttnauer electronic controlled autoclaves are intended to be used for sterilization of solid meta) instruments, solid metal hinged instrurnents, dental handpieces and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 3 cycles: unwrapped instruments (134°C at 4 minutes and 29 psi); wrapped instruments (134°C at 8 minutes and 29 psi); and liquids (121°C at 30 minutes end 16 psi). These cycles are pre-programmed and are recommended in the labeling. Tuttnauer E Series Electronic Table-top Autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.68%0.

Source page: https://510kreport.com/device/K993856
Methodology: https://510kreport.com/methodology