Cleared Traditional

K874220 - OCS 100 (OCULAR COMPARATOR SYSTEM)

K874220 is an FDA 510(k) clearance for OCS 100 (OCULAR COMPARATOR SYSTEM), manufactured by Ocular Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K874220 · Ocular Instruments, Inc. · Ophthalmic device
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Dec 1987
Decision
68d
Days
Class 2
Risk

K874220 is an FDA 510(k) clearance for the OCS 100 (OCULAR COMPARATOR SYSTEM). Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on December 23, 1987 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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.

FDA 510(k) Submission Details - K874220

510(k) Number K874220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1987
Decision Date December 23, 1987
Days to Decision 68 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
42d faster than avg
Panel avg: 110d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 108
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K874220.
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K863048 · Optek Medico Co., Ltd. · Sep 1986
CORNEAL MODELING SYSTEM
K862379 · Computed Anatomy, Inc. · Aug 1986
K874220 · OCS 100 (OCULAR COMPARATOR SYSTEM)
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