# K020334: Insulation and Continuity Tester Plus Accessories; Models ATI014 & ATI014 FC

- Pathway: 510(k) (Traditional)
- Applicant: Jac-Cell Medic Corporation
- Decided: Oct 3, 2002 after 245 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) InsulScan Insulation Testing System: named in the summary without a submission number

## Most influential descendants
- K170105: Jac-Cell Medic testers (2017), 0 descendants of its own
- K120416: Insulation Tester (2012), 0 descendants of its own
- K101606: Micromed PD-8K Insulation Defect Detector (2010), 0 descendants of its own

## Indications for use
The An-014 Insulation and Continuity Testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments.

Source page: https://510kreport.com/device/K020334
Methodology: https://510kreport.com/methodology