# K833837: American Gold Series Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer Co., Ltd.
- Decided: Jan 11, 1984 after 69 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K953938: Sterilemax (1997), 3 descendants of its own
- K112811: Saniclave 200 (2012), 2 descendants of its own
- K180272: Saniclave 250 (2018), 0 descendants of its own
- K122978: Saniclave 102, Model RS-SC-102 (2013), 0 descendants of its own
- K973550: Tuttnauer Table-Top Autoclave (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K833837
Methodology: https://510kreport.com/methodology