# K894166: Thermosurgery TM

- Pathway: 510(k) (Traditional)
- Applicant: Rdm Intl., Inc.
- Decided: Oct 3, 1989 after 110 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K021117: Tti Thermomed Model 1.8 Instrument (2002), 1 descendant of its own
- K063748: Thermomed 1.8 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K894166
Methodology: https://510kreport.com/methodology