510(k) · Cleared

Cleared

Insulscan Insulation Testing System

K991424510(k) TraditionalCleared Jul 22, 199990-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

Medicor Corp. · HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

Cleared on Jul 22, 1999 as substantially equivalent to K952889 (Materials Conversion Corp., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Jul 22, 1999
Review: 90 days
Class: Class II
Product code: HFG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952889 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK952889 Insul-Coat/2 Ceramic Coated Endo Medical InstrumentsMaterials Conversion Corp. · 1995
This deviceK991424 Insulscan Insulation Testing SystemMedicor Corp. · 1999
Descendant · cites it directly · 0 of its ownK101606 Micromed PD-8K Insulation Defect DetectorMcgan Technology, LLC · 2010

Most influential descendants

Showing 1 of 1 · See all

K101606Micromed PD-8K Insulation Defect DetectorMcgan Technology, LLC · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K991424, 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? (1)

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 1 …ication: Class II per 21 CFR 884.1720 and 844.4160 Panel Code: 85 Procodes: HET (884.1720) and HFG (884.4160) Predicate Device Accessory: LIT Insulation Testing System (K952889) Product Design: The InsulScan™ system is comprised of a disposable hand-held instrument probe, a control unit, a cable adapter…	Materials Conversion Corp.	1995	—

Also cleared against K952889: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101606	Micromed PD-8K Insulation Defect Detector	Mcgan Technology, LLC	2010	0

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?

Its one ancestor has no recall.
Of its descendants, K101606 (Mcgan Technology, LLC, 2010) has gone furthest, with 0 descendants of its own.
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.

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991424 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991424: Insulscan Insulation Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991424

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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