510(k) Report

510(k) · Cleared

Cleared

HGM Illuminating/Aspirating Endoocular Probe

K931072510(k) TraditionalCleared Nov 10, 1994618-day reviewClass II21 CFR 886.1945

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

Hgm, Inc. · HJM Transilluminator, Ac-Powered

Cleared on Nov 10, 1994 after a 618-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Nov 10, 1994
Review
618 days
Class
Class II
Product code
HJM
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 2 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK931072 HGM Illuminating/Aspirating Endoocular ProbeHgm, Inc. · 1994
  2. Descendant · cites it directly · 4 of its ownK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
  3. Descendant · 2 generations on · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
  4. Descendant · cites it directly · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
  5. Descendant · 3 generations on · 0 of its ownK123056 Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012
  6. Descendant · 2 generations on · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009

Most influential descendants

Showing 5 of 5 · See all
  • K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005 · cites it directly4descendants
  • K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · 2 generations on1descendant
  • K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · cites it directly1descendant
  • K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012 · 3 generations on0descendants
  • K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931072HGM Illuminating/Aspirating Endoocular ProbeHgm, Inc.1994—
+1K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc.2005—
+2K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation2006—
+1K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc.2006—
+3K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)2012—
+2K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200910
201210
FIG. 1 — Lineage of K931072, 1994–2012Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HJM? 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc.20054
K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc.20061

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, K052526 (Lumenis, Inc., 2005) has gone furthest, with 4 descendants of its own.

How does its category compare?

All HJM devices

HJM Transilluminator, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJM

FDA has decided no HJM device since 2007.

Median 510(k) review, days · HJM

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

Recalls per year · HJM

1in 2007

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

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HJM

1in 2016

2007: 12013: 12015: 22016: 1
2007high 2 (2015) · low 0 (2008)2025

MAUDE reports naming product code HJM, 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
20070—11
20080—00
20090—00
20100—00
20110—00
20120—00
20130—01
20140—00
20150—02
20160—01
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
  • K931784HGM Illuminating Imaging Endocular ProbeHgm, Inc. · 1994
  • K933333HGM Scanman PlusHgm, Inc. · 1993
  • K931499Q-11 Ophthalmic LaserHgm, Inc. · 1993
  • K925663HGM Aspirating Endoocular (TM) ProbeHgm, Inc. · 1993

Recent decisions in HJM

The HJM category page

  • K972506Infinitech Bullet Endo Illuminated Pick ManipulatorInfinitech, Inc. · 1997
  • K950529Peregrine Diffusion Light PipePeregrine Surgical, Ltd. · 1995
  • K945877Weco Endoscopic Systems with Fiber Optic LightWells Johnson Co. · 1995
  • K933445DPS 100 Multiport Illumination System (Mis)Storz Instrument Co. · 1994
  • K940393Peregrine Wide Angle Light PipePeregrine Surgical, Ltd. · 19941 recall

https://510kreport.com/device/K931072 · printed Nov 5, 2026

Cite this page

510(k) Report. “K931072: HGM Illuminating/Aspirating Endoocular Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931072

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