510(k) · Cleared

Cleared

Sensor Medical Family of Vitrectomy Lenses and Products

K142715510(k) TraditionalCleared Dec 16, 201485-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

Sensor Medical Technology, LLC · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

Cleared on Dec 16, 2014 as substantially equivalent to K012096 (Ocular Instruments, Inc., 2001) after an 85-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Dec 16, 2014
Review: 85 days
Class: Class II
Product code: HJK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K012096 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK012096 Disposable Vitrectomy LensOcular Instruments, Inc. · 2001
This deviceK142715 Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 2014
Descendant · cites it directly · 0 of its ownK173944 Endocular Viewing Lenses and Silicone RingPhakos · 2018

Most influential descendants

Showing 1 of 1 · See all

K173944Endocular Viewing Lenses and Silicone RingPhakos · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K012096	Disposable Vitrectomy Lens	Ocular Instruments, Inc.	2001	—
0 (this device)	K142715	Sensor Medical Family of Vitrectomy Lenses and Products	Sensor Medical Technology, LLC	2014	—
+1	K173944	Endocular Viewing Lenses and Silicone Ring	Phakos	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K142715, 2001–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K012096	Disposable Vitrectomy Lens Summary page 4 …, HJK Ophthalmic Panel Manual ophthalmic surgical instrument 21 CRF 886.4350, HNR Ophthalmic Panel Predicate Devices Ocular Instruments Disposable Vitrectomy Lens Kit (K012096) Intended Use / Indications for Use The Sensor Medical Family of Vitrectomy Lenses and Products allows visualizat…	Ocular Instruments, Inc.	2001	—

Also cleared against K012096: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K173944	Endocular Viewing Lenses and Silicone Ring	Phakos	2018	0

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.
Of its descendants, K173944 (Phakos, 2018) has gone furthest, with 0 descendants of its own.
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. 2014, this device’s year, is highlighted.

FDA decisions per year · HJK

1in 2020

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	3
2020	1	—	2
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	1
2026	0	—	—

What is it indicated for?

The Sensor Medical Family of Vitrectomy Lenses and Products allows visualization of the ocular fundus, vitreous and retinal structures during vitrectomy surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142715: Sensor Medical Family of Vitrectomy Lenses and Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142715

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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