# K962282: Tuttnauer Prevacuum Table Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer U.S.A Co, Ltd.
- Decided: Nov 12, 1997 after 518 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Tuttnauer electronic controlled pre-vacuum autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 5 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); liquids (121°C at 30 minutes and 16 psi); Bowie Dick test program (134°C at 3.5 minutes and 29 psi); and a free program with adjustable sterilization times and temperatures. With the exception of the free program, all of these cycles are pre-programmed, requiring no user input. The free program allows the user to select their own sterilization parameters, however, the operations manual warns that sterilization has not been validated for user selected settings, and cautions the user that they must validate sterilization. These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.

Source page: https://510kreport.com/device/K962282
Methodology: https://510kreport.com/methodology