Cleared Traditional

K875114 - HOSKINS-BARKAN GONIOTOMY LENS 9MM

K875114 is the FDA 510(k) clearance for HOSKINS-BARKAN GONIOTOMY LENS 9MM by Ocular Instruments, Inc.. It is a Class 2 Ophthalmic device (product code HJK) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K875114 · Ocular Instruments, Inc. · Ophthalmic device
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Feb 1988
Decision
67d
Days
Class 2
Risk

K875114 is an FDA 510(k) clearance for the HOSKINS-BARKAN GONIOTOMY LENS 9MM. 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 February 19, 1988 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ocular Instruments, Inc. devices

Submission Details

510(k) Number K875114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1987
Decision Date February 19, 1988
Days to Decision 67 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 110d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K875114.
HOSKINS-BARKAN GONIOTOMY LENS 10MM
K875330 · Ocular Instruments, Inc. · Feb 1988
BICONCAVE VITRECTOMY LENS
K875331 · Ocular Instruments, Inc. · Feb 1988
PEYMAN G. 12.12 YAG LASER LENS
K875087 · Ocular Instruments, Inc. · Feb 1988
18MM PEYMAN WIDE FIELD YAG LASER LENS
K872855 · Ocular Instruments, Inc. · Sep 1987
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
K872136 · Ocular Instruments, Inc. · Jun 1987
25MM PEYMAN WIDE FIELD YAG LASER LENS
K871450 · Ocular Instruments, Inc. · Jun 1987