510(k) Report

510(k) · Cleared

Cleared

Disposable Vitrectomy Lens

K012096510(k) TraditionalCleared Aug 24, 200150-day reviewClass II21 CFR 886.1385

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

Ocular Instruments, Inc. · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

Cleared on Aug 24, 2001 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Aug 24, 2001
Review
50 days
Class
Class II
Product code
HJK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2005: 2 descendants cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK012096 Disposable Vitrectomy LensOcular Instruments, Inc. · 2001
  2. Descendant · cites it directly · 2 of its ownK050623 Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx…Volk Optical, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK151961 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015
  4. Descendant · cites it directly · 1 of its ownK142715 Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 2014
  5. Descendant · cites it directly · 0 of its ownK173944 Endocular Viewing Lenses and Silicone RingPhakos · 2018
  6. Descendant · cites it directly · 0 of its ownK051630 Super View Disposable Biom Lens SetInsight Instruments, Inc. · 2005

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22014: 12015: 12018: 1
2004high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…Volk Optical, Inc. · 2005 · cites it directly2descendants
  • K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015 · 2 generations on1descendant
  • K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 2014 · cites it directly1descendant
  • K173944Endocular Viewing Lenses and Silicone RingPhakos · 2018 · cites it directly0descendants
  • K051630Super View Disposable Biom Lens SetInsight Instruments, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012096Disposable Vitrectomy LensOcular Instruments, Inc.2001—
+1K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D…Volk Optical, Inc.20051
+2K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc.2015—
+1K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC2014—
+1K173944Endocular Viewing Lenses and Silicone RingPhakos2018—
+1K051630Super View Disposable Biom Lens SetInsight Instruments, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
201410
201510
201810
FIG. 1 — Lineage of K012096, 2001–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HJK? 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 HJK device

  1. #1 K201909 RxSight Contact Lensscore -0.0 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…Volk Optical, Inc.20052
K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC20141
K173944Endocular Viewing Lenses and Silicone RingPhakos20180
K051630Super View Disposable Biom Lens SetInsight Instruments, Inc.20050
K033950Dorc Vitrectomy Lenses, Model 1284 SeriesDutch Ophthalmic Research Center (D.O.R.C.)20040

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, K050623 (Volk Optical, Inc., 2005) has gone furthest, with 2 descendants of its own.

How does its category compare?

All HJK devices

HJK Lens, Contact, Polymethylmethacrylate, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJK

1in 2020

2014: 12015: 12018: 12020: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HJK

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

Recalls per year · HJK

No recall names HJK since 2007.

Adverse event reports per year · HJK

1in 2025

2019: 32020: 22025: 1
2007high 3 (2019) · low 0 (2007)2025

MAUDE reports naming product code HJK, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20151—00
20160—00
20170—00
20181—00
20190—03
20201—02
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

What is it indicated for?

Allow visualization of the ocular fundus, vitreous,

and retinal structures during vitrectomy surgery.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Ocular Instruments, Inc.

50 FDA decisions under this applicant name. See the company

  • K014170Staurenghi Wide Field Scanning Laser LensOcular Instruments, Inc. · 2002
  • K933976Mandelkorn Suture Lysis LensOcular Instruments, Inc. · 1994
  • K933264Ritch Nylon Suture Laser LensOcular Instruments, Inc. · 1994
  • K94142050 Degree Hri Prism LensOcular Instruments, Inc. · 1994
  • K935302Osher Surgical Gonio/Posterior Pole LensOcular Instruments, Inc. · 1994

Recent decisions in HJK

The HJK category page

  • K201909RxSight Contact LensRxsight, Inc. · 2020
  • K173944Endocular Viewing Lenses and Silicone RingPhakos · 2018
  • K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015
  • K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 2014
  • K051630Super View Disposable Biom Lens SetInsight Instruments, Inc. · 2005

https://510kreport.com/device/K012096 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012096: Disposable Vitrectomy Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012096

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026