Cleared Traditional

K914051 - PEDIATRIC VITRECTOMY LENS SET

K914051 is an FDA 510(k) clearance for PEDIATRIC VITRECTOMY LENS SET, manufactured by Ocular Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HJK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914051 · Ocular Instruments, Inc. · Ophthalmic device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K914051 is an FDA 510(k) clearance for the PEDIATRIC VITRECTOMY LENS SET. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ocular Instruments, Inc. devices

FDA 510(k) Submission Details - K914051

510(k) Number K914051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date December 09, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJK Device Classification - Class 2, Special Controls

Product Code HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 33
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K914051.
MANDELKORN SUTURE LYSIS LENS
K933976 · Ocular Instruments, Inc. · Nov 1994
RITCH NYLON SUTURE LASER LENS
K933264 · Ocular Instruments, Inc. · Oct 1994
50 DEGREE HRI PRISM LENS
K941420 · Ocular Instruments, Inc. · Aug 1994
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
K914117 · Ocular Instruments, Inc. · Nov 1991
MAINSTER HIGH MAGNIFICATION LASER LENS
K912366 · Ocular Instruments, Inc. · Jun 1991
NMR-K FUNDUS LASER LENS
K910231 · Ocular Instruments, Inc. · Jan 1991