510(k) Report

510(k) · Cleared

Cleared

D.O.R.C. Microdiathermy System

K962135510(k) TraditionalCleared Aug 29, 199687-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

Dutch Ophthalmic USA, Inc. · HQO Unit, Cautery, Thermal, Ac-Powered

Cleared on Aug 29, 1996 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Aug 29, 1996
Review
87 days
Class
Class II
Product code
HQO
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962135 D.O.R.C. Microdiathermy SystemDutch Ophthalmic USA, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK990064 DI-Rhex Ophthalmic Diathermy SystemOphthalmic Technologies, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K990064DI-Rhex Ophthalmic Diathermy SystemOphthalmic Technologies, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962135D.O.R.C. Microdiathermy SystemDutch Ophthalmic USA, Inc.1996—
+1K990064DI-Rhex Ophthalmic Diathermy SystemOphthalmic Technologies, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K962135, 1996–1999Source: 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 HQO? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K990064DI-Rhex Ophthalmic Diathermy SystemOphthalmic Technologies, Inc.19990

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, K990064 (Ophthalmic Technologies, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HQO devices

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

FDA decisions per year · HQO

1in 2007

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

2026 to Oct 25, outlined.

Median 510(k) review, days · HQO

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

Recalls per year · HQO

No recall names HQO since 2007.

Adverse event reports per year · HQO

101in 2025

2010: 132011: 302012: 292013: 402014: 552015: 422016: 562018: 172019: 732020: 442021: 562022: 532023: 482024: 662025: 101
2007high 101 (2025) · low 0 (2007)2025

MAUDE reports naming product code HQO, 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—00
20090—00
20100—013
20110—030
20120—029
20130—040
20140—055
20150—042
20160—056
20170—00
20180—017
20190—073
20200—044
20210—056
20220—053
20230—048
20240—066
20250—0101
20260—0—

More from Dutch Ophthalmic USA, Inc.

10 FDA decisions under this applicant name. See the company

  • K012821D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc. · 2001
  • K010082D.O.R.C. Harmony Total TTC Vitrectomy SystemDutch Ophthalmic USA, Inc. · 2001
  • K983797D.O.R.C. Harmony Total Vitrectomy SystemDutch Ophthalmic USA, Inc. · 1999
  • K980636Fiber Optic Endoillumination ProbeDutch Ophthalmic USA, Inc. · 1998
  • K973229D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc. · 1997

Recent decisions in HQO

The HQO category page

  • K070871Starion Universal Power SupplyStarion Instruments · 2007
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 2004
  • K002341Thermal Cautery Unit, Model 150Geiger Medical Technologies, Inc. · 2000
  • K000893AC Powered Thermal Cautery UnitStarion Instruments · 2000
  • K971538Mentor Gemini Hemostatic EraserMentor Ophthalmics, Inc. · 1997

https://510kreport.com/device/K962135 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962135: D.O.R.C. Microdiathermy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962135

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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