# K991424: Insulscan Insulation Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Medicor Corp.
- Decided: Jul 22, 1999 after 90 days
- Product code: HFG (Coagulator, Laparoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- 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 K952889 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K952889: Insul-Coat/2 Ceramic Coated Endo Medical Instruments, Materials Conversion Corp. (1995) Summary page 1.

## Most influential descendants
- K101606: Micromed PD-8K Insulation Defect Detector (2010), 0 descendants of its own

## Indications for use
The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.

Source page: https://510kreport.com/device/K991424
Methodology: https://510kreport.com/methodology