# K970493: Hyfrecator 2000

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Labs
- Decided: Apr 30, 1997 after 79 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K063748: Thermomed 1.8 (2007), 0 descendants of its own

## Recalls of this device
- Sep 15, 2003 · Not classified · Z-0144-04: The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.

Source page: https://510kreport.com/device/K970493
Methodology: https://510kreport.com/methodology