# K101606: Micromed PD-8K Insulation Defect Detector

- Pathway: 510(k) (Traditional)
- Applicant: Mcgan Technology, LLC
- Decided: Oct 1, 2010 after 115 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: 2 generations back to K952889 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 2.
- K991424: Insulscan Insulation Testing System, Medicor Corp. (1999) Summary page 2.
- K020334: Insulation and Continuity Tester Plus Accessories; Models ATI014 & ATI014 FC, Jac-Cell Medic Corporation (2002) Summary page 2.

## Indications for use
The MicroMed PD-8K kit or system is a non-destructive, no-arc high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.

Source page: https://510kreport.com/device/K101606
Methodology: https://510kreport.com/methodology