510(k) · Cleared

Cleared

HGM Aspirating Endoocular (TM) Probe

K925663510(k) TraditionalCleared Aug 17, 1993280-day reviewClass II21 CFR 886.4390

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

Hgm, Inc. · HQF Laser, Ophthalmic

Cleared on Aug 17, 1993 after a 280-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: Aug 17, 1993
Review: 280 days
Class: Class II
Product code: HQF
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK925663 HGM Aspirating Endoocular (TM) ProbeHgm, Inc. · 1993
Descendant · cites it directly · 1 of its ownK022228 Family of Iris Medical Endoprobe HandpiecesIridex Corp · 2002
Descendant · 2 generations on · 0 of its ownK133019 Fiberion Ophthalmic Endolaser ProbeEmtron Elektronik VE Mekanik Sanayi VE Ticaret Lim · 2015

Most influential descendants

Showing 2 of 2 · See all

K022228Family of Iris Medical Endoprobe HandpiecesIridex Corp · 2002 · cites it directly1descendant
K133019Fiberion Ophthalmic Endolaser ProbeEmtron Elektronik VE Mekanik Sanayi VE Ticaret Lim · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K925663	HGM Aspirating Endoocular (TM) Probe	Hgm, Inc.	1993	—
+1	K022228	Family of Iris Medical Endoprobe Handpieces	Iridex Corp	2002	—
+2	K133019	Fiberion Ophthalmic Endolaser Probe	Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2015	1	0

FIG. 1 — Lineage of K925663, 1993–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Top candidate predicates for a new HQF device

#1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
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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? (2)

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

Number	Device	Applicant	Decided	Descendants
K022228	Family of Iris Medical Endoprobe Handpieces	Iridex Corp	2002	1

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, K022228 (Iridex Corp, 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQF

3in 2025

2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007high 295 (2015) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQF

1in 2025

2007high 5 (2011) · low 0 (2015)2026

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

Adverse event reports per year · HQF

106in 2025

2007high 111 (2022) · low 26 (2011)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	198	2	60
2008	3	28	1	34
2009	7	115	2	33
2010	2	—	3	43
2011	4	128	5	26
2012	5	179	1	41
2013	6	225	2	39
2014	3	215	4	58
2015	4	295	0	80
2016	3	271	0	108
2017	3	189	0	77
2018	1	—	0	82
2019	4	107	0	66
2020	4	53	0	72
2021	1	—	0	100
2022	7	86	0	111
2023	5	155	0	92
2024	3	167	0	75
2025	3	264	1	106
2026	2	—	0	—

https://510kreport.com/device/K925663 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925663: HGM Aspirating Endoocular (TM) Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925663

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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