# K222608: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer, Ltd.
- Decided: Dec 16, 2022 after 109 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: 6 generations back to K003470 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143311: Pre-vacuum Tabletop Autoclave, Tuttnauer U.S.A Co, Ltd. (2015) Summary page 5.

## Indications for use
The pre-vacuum steam sterilizer models 3870HSG and 3870HSG-WS are intended for use in hospitals and other health- care facilities (e.g. hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices) for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products. The following table show the preprogrammed cycles, including sterilization temperature, sterilization time (in minutes), dry time (in minutes) and maximum load:

Source page: https://510kreport.com/device/K222608
Methodology: https://510kreport.com/methodology