Cleared Traditional

K875030 - OCU-1

K875030 is an FDA 510(k) clearance for OCU-1, manufactured by Rudolph Beaver, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K875030 · Rudolph Beaver, Inc. · Ophthalmic device
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May 1988
Decision
148d
Days
Class 1
Risk

K875030 is an FDA 510(k) clearance for the OCU-1. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Rudolph Beaver, Inc. (Waltham, US). The FDA issued a Cleared decision on May 3, 1988 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Rudolph Beaver, Inc. devices

FDA 510(k) Submission Details - K875030

510(k) Number K875030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date May 03, 1988
Days to Decision 148 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 110d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HMX Cannula, Ophthalmic

All 49
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K875030.
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
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VITREORETINAL INFUSION CANNULA
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STORZ INFUSION CANNULA
K882884 · Storz Instrument Co. · Aug 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
K874968 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE KRATZ CAPSULE POLISHER
K874969 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
K874970 · Advanced Surgical Products, Inc. · Apr 1988