510(k) Report

510(k) · Cleared

Cleared

Endocular Viewing Lenses and Silicone Ring

K173944510(k) TraditionalCleared Oct 25, 2018303-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

Phakos · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

Cleared on Oct 25, 2018 as substantially equivalent to K012096 (Ocular Instruments, Inc., 2001) and 4 other predicates after a 303-day review. Its family tree reaches back 3 generations to 1994.

Decided
Oct 25, 2018
Review
303 days
Class
Class II
Product code
HJK
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K943125 (1994). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 2 other ancestors2001: 1 other ancestor2002: 1 other ancestorK943125 · Quadraspheric Fundus Lens · Volk Optical, Inc. · 1994K050623 · Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D · Volk Optical, Inc. · 2005 · recalledK151961 · Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens · Volk Optical, Inc. · 20151990199520002005201020152020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K151961 · Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens · Volk Optical, Inc. · 2015K050623 · Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D · Volk Optical, Inc. · 2005 · recalledK943125 · Quadraspheric Fundus Lens · Volk Optical, Inc. · 19940
  1. Root · 3 generations backK943125 Quadraspheric Fundus LensVolk Optical, Inc. · 1994
  2. 2 generations backK050623 Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx…Volk Optical, Inc. · 2005 · Recalled
  3. 1 generation backK151961 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015
  4. This deviceK173944 Endocular Viewing Lenses and Silicone RingPhakos · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K943125Quadraspheric Fundus LensVolk Optical, Inc.1994—
−2K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D…Volk Optical, Inc.20051
−1K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc.2015—
0 (this device)K173944Endocular Viewing Lenses and Silicone RingPhakos2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
201420
FIG. 1 — Lineage of K173944, 1994–2018Source: 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 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? (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
*K012096Disposable Vitrectomy Lens
Summary page 4
…21 CFR section 886.1385 Device Panel Ophthalmic Primary Predicate Disposable Vitrectomy Lens, OCULAR Instruments, Inc. (K012096) Device Secondary Predicate Disposable Vitrectomy Lens, VOLK Optical, Inc. (K050623/ K151961) Devices Fami…
Ocular Instruments, Inc.2001—
*K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…
Summary page 4
…Disposable Vitrectomy Lens, OCULAR Instruments, Inc. (K012096) Device Secondary Predicate Disposable Vitrectomy Lens, VOLK Optical, Inc. (K050623/ K151961) Devices Family of Vitrectomy Lenses, SENSOR Medical Technology LLC (K140368/ K142715)…
Volk Optical, Inc.20051
*K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
Summary page 4
…Disposable Vitrectomy Lens, OCULAR Instruments, Inc. (K012096) Device Secondary Predicate Disposable Vitrectomy Lens, VOLK Optical, Inc. (K050623/ K151961) Devices Family of Vitrectomy Lenses, SENSOR Medical Technology LLC (K140368/ K142715)…
Volk Optical, Inc.2015—
*K140368Family of Disposable Lenses
Summary page 4
…ary Predicate Disposable Vitrectomy Lens, VOLK Optical, Inc. (K050623/ K151961) Devices Family of Vitrectomy Lenses, SENSOR Medical Technology LLC (K140368/ K142715) The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices…
Sensor Medical Technology, LLC2014—
*K142715Sensor Medical Family of Vitrectomy Lenses and Products
Summary page 4
…cate Disposable Vitrectomy Lens, VOLK Optical, Inc. (K050623/ K151961) Devices Family of Vitrectomy Lenses, SENSOR Medical Technology LLC (K140368/ K142715) The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices c…
Sensor Medical Technology, LLC2014—

Also cleared against K012096: 4 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?

  • The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K012096.

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. 2018, this device’s year, is highlighted.

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?

The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

Indications for use as stated in the FDA summary.

Also cleared against K012096

4 other devices cite the same predicate.

  • K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 2014
  • K051630Super View Disposable Biom Lens SetInsight Instruments, Inc. · 2005
  • K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV DVolk Optical, Inc. · 20051 recall
  • K033950Dorc Vitrectomy Lenses, Model 1284 SeriesDutch Ophthalmic Research Center (D.O.R.C.) · 2004

More from Phakos

4 FDA decisions under this applicant name. See the company

  • K200911MIRA AdapterPhakos · 2020
  • K180195Frigitronics adapterPhakos · 2018
  • K162756PHAKOS Disposable Retinal Cryo ProbePhakos · 2017

Recent decisions in HJK

The HJK category page

  • K201909RxSight Contact LensRxsight, Inc. · 2020
  • 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
  • K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005

https://510kreport.com/device/K173944 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173944: Endocular Viewing Lenses and Silicone Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173944

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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