510(k) Report

510(k) · Cleared

Cleared

Surgical Medical Device Cautery

K023506510(k) TraditionalCleared Jan 13, 2004452-day reviewClass II21 CFR 886.4115

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

Modern Medical Equipment Mfg., Ltd. · HQP Unit, Cautery, Thermal, Battery-Powered

Cleared on Jan 13, 2004 after a 452-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.

Decided
Jan 13, 2004
Review
452 days
Class
Class II
Product code
HQP
Recalls
None
Predicates
0

25 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2017: 2 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2018: 2 descendants cleared2022: 3 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2026: 3 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2020: 2 descendants cleared200020052010201520202025
  1. This deviceK023506 Surgical Medical Device CauteryModern Medical Equipment Mfg., Ltd. · 2004
  2. Descendant · cites it directly · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
  3. Descendant · 2 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
  4. Descendant · 3 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
  5. Descendant · 4 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
  6. Descendant · 5 generations on · 6 of its ownK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12010: 12015: 22016: 22017: 22018: 22019: 12020: 22022: 32023: 12024: 22025: 12026: 3
2006high 3 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 25 · See all
  • K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · cites it directly23descendants
  • K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 2 generations on16descendants
  • K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 3 generations on8descendants
  • K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 4 generations on7descendants
  • K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023506Surgical Medical Device CauteryModern Medical Equipment Mfg., Ltd.2004—
+1K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…New Wave Surgical Corporation20062
+2K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC2008—
+3K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2015—
+4K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2016—
+5K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
201010
201520
201620
201720
201820
201910
202020
202230
202310
202420
202510
202630
FIG. 1 — Lineage of K023506, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in HQP? 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (25)

See all 25

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation200623
K061307Bovie Inaflash Suture Remover Handle,Charger,Handle and Charger,Kit,Battery PackAaron Medical Industries20060

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?

  • Of its descendants, K062779 (New Wave Surgical Corporation, 2006) has gone furthest, with 23 descendants of its own.

How does its category compare?

All HQP devices

HQP Unit, Cautery, Thermal, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQP

1in 2012

2007: 12009: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQP

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

Recalls per year · HQP

No recall names HQP since 2007.

Adverse event reports per year · HQP

22in 2025

2008: 12009: 22010: 32013: 12016: 22017: 12018: 32019: 22020: 32021: 22022: 72023: 82024: 232025: 22
2007high 23 (2024) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—01
20091—02
20100—03
20110—00
20121—00
20130—01
20140—00
20150—00
20160—02
20170—01
20180—03
20190—02
20200—03
20210—02
20220—07
20230—08
20240—023
20250—022
20260—0—

What is it indicated for?

The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cauterize small blood vessels to help reduce blood loss and keep the surgical site clear of excess blood. Use for controlling diffuse bleeding and sculpting woven grafts.

Indications for use as stated in the FDA 510(k) statement.

More from Modern Medical Equipment Mfg., Ltd.

14 FDA decisions under this applicant name. See the company

  • K093479Disposable Suction and Irrigation SystemModern Medical Equipment Mfg., Ltd. · 2010
  • K091511Modern Medical Resectoscope ElectrodesModern Medical Equipment Mfg., Ltd. · 2010
  • K070812Disposable Laparoscopic InstrumentModern Medical Equipment Mfg., Ltd. · 2007
  • K070877Endocervical Electrode # 2Modern Medical Equipment Mfg., Ltd. · 2007
  • K050842Agcel Wound Dressing,Agcel Burn DressingModern Medical Equipment Mfg., Ltd. · 2006

Recent decisions in HQP

The HQP category page

  • K121441Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)Bovie Medical Corporation · 2012
  • K083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 Series of Battery-Powered CauteryFiab Spa · 2009
  • K062659Kirwan Disposable Battery-Powered Cautery, Model 41-61XX SeriesKirwan Surgical Products, Inc. · 2007
  • K002547Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 2000
  • K994019Cautery Grasper/DissectorStarion Instruments · 2000

https://510kreport.com/device/K023506 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023506: Surgical Medical Device Cautery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023506

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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