# K170105: Jac-Cell Medic testers

- Pathway: 510(k) (Traditional)
- Applicant: Jac-Cell Medic
- Decided: Feb 28, 2017 after 47 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 4.

## Indications for use
The ATI-014A insulation and continuity testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments. The ATI-021 has the same indications for use for insulation testing, but does not include continuity testing.

Source page: https://510kreport.com/device/K170105
Methodology: https://510kreport.com/methodology