# K063711: Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L Usa SP-2A, 69180 SP-2HA

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer Co., Ltd.
- Decided: Feb 2, 2007 after 50 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: 2 generations back to K003470 (2001). 3 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850264: Tuttnauer Pre-Vacuum Autoclave, Tuttnauer Co., Ltd. (1985) Summary page 2.
- K032192: Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models 4472 EP-1V and 5596 EP-1V, Tuttnauer U.S.A Co, Ltd. (2004) Summary page 2.

## Most influential descendants
- 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
- K232658: T-Top 10 & T-Top T-Top 11 (2023), 1 descendant of its own

## Indications for use
This Tuttnauer autoclave is designed for use in healthcare settings for the sterilization of heat stable medical devices; wrapped solids, hollow and porous products. Sterilization of liquid loads should only be used in non-clinical applications in open or closed (but not sealed) containers.

Source page: https://510kreport.com/device/K063711
Methodology: https://510kreport.com/methodology