# K120416: Insulation Tester

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Surgical Supply Corp.
- Decided: Mar 27, 2012 after 46 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
Longest line of descent: 1 generation back to K020334 (2002). 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)
- K020334: Insulation and Continuity Tester Plus Accessories; Models ATI014 & ATI014 FC, Jac-Cell Medic Corporation (2002) Summary page 1.

## Indications for use
The Spectrum Insulation Tester checks for insulation integrity on laparoscopic instruments

Source page: https://510kreport.com/device/K120416
Methodology: https://510kreport.com/methodology