510(k) Report

510(k) · Cleared

Cleared

Super View Disposable Biom Lens Set

K051630510(k) TraditionalCleared Jun 29, 200512-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

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

Cleared on Jun 29, 2005 as substantially equivalent to K012096 (Ocular Instruments, Inc., 2001) after a 12-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jun 29, 2005
Review
12 days
Class
Class II
Product code
HJK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K012096 (2001). No later device cites it as a predicate yet.

K012096 · Disposable Vitrectomy Lens · Ocular Instruments, Inc. · 20012000200220042006
K012096 · Disposable Vitrectomy Lens · Ocular Instruments, Inc. · 20010
  1. Root · 1 generation backK012096 Disposable Vitrectomy LensOcular Instruments, Inc. · 2001
  2. This deviceK051630 Super View Disposable Biom Lens SetInsight Instruments, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012096Disposable Vitrectomy LensOcular Instruments, Inc.2001—
0 (this device)K051630Super View Disposable Biom Lens SetInsight Instruments, Inc.2005—
FIG. 1 — Lineage of K051630, 2001–2005Source: 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
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What was it cleared against? (1)

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 2
…ended use and indications to vitrectomy lenses marketed by Ocular Instruments, Inc. cleared via 510(k) number K012096, 8/24/01. 6 Insight Instruments, Inc. 4/2005…
Ocular Instruments, Inc.2001—

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?

  • Its one ancestor has no recall.
  • 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.

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 vitreoretinal surgery.

Indications for use as stated in the FDA summary.

Also cleared against K012096

4 other devices cite the same predicate.

  • K173944Endocular Viewing Lenses and Silicone RingPhakos · 2018
  • K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 2014
  • 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

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

https://510kreport.com/device/K051630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051630: Super View Disposable Biom Lens Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051630

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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