510(k) Report

510(k) · Cleared

Cleared

Staurenghi Wide Field Scanning Laser Lens

K014170510(k) TraditionalCleared Mar 4, 200274-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 Mar 4, 2002 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Mar 4, 2002
Review
74 days
Class
Class II
Product code
HJK
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared200020052010201520202025
  1. This deviceK014170 Staurenghi Wide Field Scanning Laser LensOcular Instruments, Inc. · 2002
  2. Descendant · cites it directly · 1 of its ownK051103 Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005
  3. Descendant · 2 generations on · 0 of its ownK052674 Contact Lens OphthalmodynamometerMeditron, GmbH · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005 · cites it directly1descendant
  • K052674Contact Lens OphthalmodynamometerMeditron, GmbH · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K014170Staurenghi Wide Field Scanning Laser LensOcular Instruments, Inc.2002—
+1K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc.2005—
+2K052674Contact Lens OphthalmodynamometerMeditron, GmbH2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
FIG. 1 — Lineage of K014170, 2002–2006Source: 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 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc.20051

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, K051103 (Haag-Streit USA, Inc., 2005) has gone furthest, with 1 descendant 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?

The Staurenghi Wide Field Scanning laser lens is indicated for use whenever a wide field view of the ocular fundus with a scanning laser ophthalmoscope is indicated.

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

  • K012096Disposable Vitrectomy LensOcular Instruments, Inc. · 2001
  • 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/K014170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014170: Staurenghi Wide Field Scanning Laser Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014170

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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