510(k) Report

510(k) · Cleared

Cleared

Endocoagulator Model 5, 8 & 20 Argon Laser

K871424510(k) TraditionalCleared Jul 8, 198790-day reviewClass II21 CFR 874.4490

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

Hgm, Inc. · LMS Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology

Cleared on Jul 8, 1987 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 8, 1987
Review
90 days
Class
Class II
Product code
LMS
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K871424Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All LMS devices

LMS Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMS

FDA has decided no LMS device since 2007.

Median 510(k) review, days · LMS

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

Recalls per year · LMS

No recall names LMS since 2007.

Adverse event reports per year · LMS

No MAUDE report names LMS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Hgm, Inc.

23 FDA decisions under this applicant name. See the company

  • K950120Smart PlugHgm, Inc. · 1995
  • K931072HGM Illuminating/Aspirating Endoocular ProbeHgm, Inc. · 1994
  • K931784HGM Illuminating Imaging Endocular ProbeHgm, Inc. · 1994
  • K933333HGM Scanman PlusHgm, Inc. · 1993
  • K931499Q-11 Ophthalmic LaserHgm, Inc. · 1993

Recent decisions in LMS

The LMS category page

  • K855146Laserscope Omniplus Photosurgical Syst/ND:Yag OtolLaserscope · 1986

https://510kreport.com/device/K871424 · printed Nov 4, 2026

Cite this page

510(k) Report. “K871424: Endocoagulator Model 5, 8 & 20 Argon Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871424

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026