510(k) Report

510(k) · Cleared

Cleared

D.O.R.C. Harmony Total Vitrectomy System

K983797510(k) TraditionalCleared Mar 3, 1999126-day reviewClass II21 CFR 886.4150

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. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Cleared on Mar 3, 1999 as substantially equivalent to K961310 (Storz Instrument Co., 1996) and 3 other predicates after a 126-day review. Its family tree reaches back 1 generation to 1993.

Decided
Mar 3, 1999
Review
126 days
Class
Class II
Product code
HQE
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K924222 (1993). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestors1994: 1 other ancestorK924222 · Mid Labs, Inc. Vit Mate · Medical Instrument Development Laboratories, Inc. · 1993199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors K924222 · Mid Labs, Inc. Vit Mate · Medical Instrument Development Laboratories, Inc. · 19930
  1. Root · 1 generation backK924222 Mid Labs, Inc. Vit MateMedical Instrument Development Laboratories, Inc. · 1993
  2. This deviceK983797 D.O.R.C. Harmony Total Vitrectomy SystemDutch Ophthalmic USA, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924222Mid Labs, Inc. Vit MateMedical Instrument Development Laboratories, Inc.1993—
0 (this device)K983797D.O.R.C. Harmony Total Vitrectomy SystemDutch Ophthalmic USA, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199620
FIG. 1 — Lineage of K983797, 1993–1999Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HQE? 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 HQE device

  1. #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K961310Storz Premiere II Microsurgical System (CX Series)
Summary page 1
…us Aspiration & Cutting Instrument (86HQE & 21CFR 886.4150) PREDICATE DEVICE/S Manufacturer Product Name 510(k) Number Alcon Surgical Accurus unknown Storz Millenium K961310 MID Labs SupraVit/VitMate K932669/K924222 Scieran Vit Commander K961738 DEVICE DESCRIPTION The D.O.R.C. Harmony Total Vitrect…
Storz Instrument Co.19961
*K932669Supra-Vit (TM)
Summary page 1
…(86HQE & 21CFR 886.4150) PREDICATE DEVICE/S Manufacturer Product Name 510(k) Number Alcon Surgical Accurus unknown Storz Millenium K961310 MID Labs SupraVit/VitMate K932669/K924222 Scieran Vit Commander K961738 DEVICE DESCRIPTION The D.O.R.C. Harmony Total Vitrectomy System is an integrated system…
Medical Instrument Development Laboratories, Inc.1994—
*K924222Mid Labs, Inc. Vit Mate
Summary page 1
…21CFR 886.4150) PREDICATE DEVICE/S Manufacturer Product Name 510(k) Number Alcon Surgical Accurus unknown Storz Millenium K961310 MID Labs SupraVit/VitMate K932669/K924222 Scieran Vit Commander K961738 DEVICE DESCRIPTION The D.O.R.C. Harmony Total Vitrectomy System is an integrated system for post…
Medical Instrument Development Laboratories, Inc.1993—
*K961738Vit Commander System
Summary page 1
…ICE/S Manufacturer Product Name 510(k) Number Alcon Surgical Accurus unknown Storz Millenium K961310 MID Labs SupraVit/VitMate K932669/K924222 Scieran Vit Commander K961738 DEVICE DESCRIPTION The D.O.R.C. Harmony Total Vitrectomy System is an integrated system for posterior segment eye surgery. It p…
Scieran Technologies, Inc.1996—
*—Accurus
Named without a submission number
—

Also cleared against K961310: 10 other devices →

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.

What does this lineage say?

  • 1 of the 4 ancestors has a recall of any class.
  • 10 other devices also cite its predicate K961310.

How does its category compare?

All HQE devices

HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQE

1in 2022

2011: 12012: 22014: 12016: 12017: 12022: 1
2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQE

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

Recalls per year · HQE

1in 2025

2007: 22010: 112016: 42025: 12026 (partial year): 3
2007high 11 (2010) · low 0 (2008)2026

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

Adverse event reports per year · HQE

339in 2025

2007: 3002008: 652009: 342010: 272011: 212012: 342013: 92014: 92015: 92016: 102017: 592018: 3092019: 412020: 302021: 322022: 462023: 1082024: 1052025: 339
2007high 339 (2025) · low 9 (2013)2025

MAUDE reports naming product code HQE, 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—2300
20080—065
20090—034
20100—1127
20111—021
20122—034
20130—09
20141—09
20150—09
20161—410
20171—059
20180—0309
20190—041
20200—030
20210—032
20221—046
20230—0108
20240—0105
20250—1339
20260—3—

What is it indicated for?

The D.O.R.C. Harmony Total vitrectomy system is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K961310

10 other devices cite the same predicate.

  • K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 20101 recall
  • K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 20094 recalls
  • K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009
  • K063583Alcon Vision SystemAlcon · 200811 recalls
  • K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 200612 recalls
  • K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 20061 recall

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
  • K980636Fiber Optic Endoillumination ProbeDutch Ophthalmic USA, Inc. · 1998
  • K973229D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc. · 1997
  • K973757D.O.R.C. Solux Light SourceDutch Ophthalmic USA, Inc. · 1997

Recent decisions in HQE

The HQE category page

  • K212763UniVit HE, UniVit UHSVisioncare Devices, LLC · 2022
  • K170183Cetus system, Cetus probeA.R.C Laser GmbH · 2017
  • K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016
  • K141065Constellation Vision SystemAlcon Research, Ltd. · 20146 recalls
  • K121675VersavitSynergetics, Inc. · 20124 recalls

https://510kreport.com/device/K983797 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983797: D.O.R.C. Harmony Total Vitrectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983797

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026