510(k) Report

510(k) · Cleared

Cleared

Aspirating Endo Ocular Probe W/Illumination

K921488510(k) TraditionalCleared May 7, 199238-day reviewClass I21 CFR 886.4350

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

Surgical Technologies, Inc. · HMX Cannula, Ophthalmic

Cleared on May 7, 1992 after a 38-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
May 7, 1992
Review
38 days
Class
Class I
Product code
HMX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK921488 Aspirating Endo Ocular Probe W/IlluminationSurgical Technologies, Inc. · 1992
  2. Descendant · cites it directly · 1 of its ownK022228 Family of Iris Medical Endoprobe HandpiecesIridex Corp · 2002
  3. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921488Aspirating Endo Ocular Probe W/IlluminationSurgical Technologies, Inc.1992—
+1K022228Family of Iris Medical Endoprobe HandpiecesIridex Corp2002—
+2K133019Fiberion Ophthalmic Endolaser ProbeEmtron Elektronik VE Mekanik Sanayi VE Ticaret Lim2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201510
FIG. 1 — Lineage of K921488, 1992–2015Source: 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 HMX? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K022228Family of Iris Medical Endoprobe HandpiecesIridex Corp20021

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 HMX devices

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

FDA decisions per year · HMX

FDA has decided no HMX device since 2007.

Median 510(k) review, days · HMX

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

Recalls per year · HMX

1in 2025

2007: 12008: 12010: 62012: 1, 1 Class I2013: 12018: 22019: 62025: 1
2007high 6 (2010) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HMX

101in 2025

2007: 42008: 92009: 122010: 142011: 112012: 142013: 82014: 182015: 182016: 362017: 272018: 382019: 272020: 272021: 412022: 462023: 932024: 1002025: 101
2007high 101 (2025) · low 4 (2007)2025

MAUDE reports naming product code HMX, 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—14
20080—19
20090—012
20100—614
20110—011
20120—1 (1)14
20130—18
20140—018
20150—018
20160—036
20170—027
20180—238
20190—627
20200—027
20210—041
20220—046
20230—093
20240—0100
20250—1101
20260—0—

More from Surgical Technologies, Inc.

28 FDA decisions under this applicant name. See the company

  • K941992CystoscopeSurgical Technologies, Inc. · 1995
  • K942029ArthroscopeSurgical Technologies, Inc. · 1995
  • K946136Infinitech Lighted Infusion CannulaSurgical Technologies, Inc. · 1995
  • K952566OscilflatorSurgical Technologies, Inc. · 1995
  • K951918Surgical Technologies, Inc. SyringeSurgical Technologies, Inc. · 1995

Recent decisions in HMX

The HMX category page

  • K010305Weiss Retinal CannulaMicron Surgical, Inc. · 2001
  • K000457Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000…Retinalabs.Com · 2000
  • K970873Endosoft Soft Tip Needle (20 GA. and 19 GA.)American Medical Devices, Inc. · 1997
  • K943932Steriseal Ophthalmic CannulaPharma-Plast, Ltd. · 1995
  • K942403Infusion CannulaMicrosurgical Technology, Inc. · 1994

https://510kreport.com/device/K921488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921488: Aspirating Endo Ocular Probe W/Illumination.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921488

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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