510(k) · Cleared

Cleared

Micromed PD-8K Insulation Defect Detector

K101606510(k) TraditionalCleared Oct 1, 2010115-day reviewClass II21 CFR 884.4160

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mcgan Technology, LLC · HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

Cleared on Oct 1, 2010 as substantially equivalent to K952889 (Materials Conversion Corp., 1995) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1995.

Decided: Oct 1, 2010
Review: 115 days
Class: Class II
Product code: HFG
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K952889 (1995). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK952889 Insul-Coat/2 Ceramic Coated Endo Medical InstrumentsMaterials Conversion Corp. · 1995
1 generation backK991424 Insulscan Insulation Testing SystemMedicor Corp. · 1999
This deviceK101606 Micromed PD-8K Insulation Defect DetectorMcgan Technology, LLC · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K952889	Insul-Coat/2 Ceramic Coated Endo Medical Instruments	Materials Conversion Corp.	1995	—
−1	K991424	Insulscan Insulation Testing System	Medicor Corp.	1999	—
0 (this device)	K101606	Micromed PD-8K Insulation Defect Detector	Mcgan Technology, LLC	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K101606, 1995–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HFG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K952889	Insul-Coat/2 Ceramic Coated Endo Medical Instruments Summary page 2 …sory: LIT Insulation Testing system (K952889) InsulScanTm Electrosurgical…	Materials Conversion Corp.	1995	—
*	K991424	Insulscan Insulation Testing System Summary page 2 …(Mobile Instruments) (K99 1424) ATI-014 Insulation and…	Medicor Corp.	1999	—
*	K020334	Insulation and Continuity Tester Plus Accessories; Models ATI014 & ATI014 FC Summary page 2 …Jac-cell Medic Canada (K020334 155) Intended Uses/indications: The MicroMed PD-SK system is a non-destructive, no-ain otchigh voltage ins…	Jac-Cell Medic Corporation	2002	—

Also cleared against K952889: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K952889.

How does its category compare?

All HFG devices

HFG Coagulator, Laparoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HFG

1in 2018

2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HFG

Too few HFG 510(k)s in any year since 2007 to give a median.

Recalls per year · HFG

No recall names HFG since 2007.

Adverse event reports per year · HFG

32in 2025

2007high 36 (2023) · low 0 (2008)2025

MAUDE reports naming product code HFG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	2
2008	0	—	0
2009	0	—	2
2010	1	—	2
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	2	—	3
2015	0	—	2
2016	0	—	5
2017	0	—	2
2018	1	—	3
2019	0	—	5
2020	0	—	6
2021	0	—	20
2022	0	—	20
2023	0	—	36
2024	0	—	21
2025	0	—	32
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101606: Micromed PD-8K Insulation Defect Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101606

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026