# K221227: Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer, Ltd.
- Decided: Sep 20, 2022 after 145 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 K181456 (2019). 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)
- K181456: Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves, Tuttnauer, Ltd. (2019) Summary page 7.

## Indications for use
The Tuttnauer Horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices are autoclaves that are intended to provide sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products. The following tables show the validated cycles, including sterilization temperature, sterilization time (in minutes), dry time (in minutes) and maximum load for tools (in kilograms) and textile (in packs) for each of the models mentioned:

Source page: https://510kreport.com/device/K221227
Methodology: https://510kreport.com/methodology