Cleared Traditional

SLIMCATH (TM) (K903001) - FDA 510(k) Clearance

Class I Ophthalmic device.

K903001 · Gynopharma, Inc. · Ophthalmic device
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Jun 1991
Decision
351d
Days
Class 1
Risk

K903001 is an FDA 510(k) clearance for the SLIMCATH (TM). Classified as Tester, Color Vision (product code HIT), Class I - General Controls.

Submitted by Gynopharma, Inc. (Princeton, US). The FDA issued a Cleared decision on June 25, 1991 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1170 - 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. Elevated predicate reliance profile. 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 Gynopharma, Inc. devices

Submission Details

510(k) Number K903001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1990
Decision Date June 25, 1991
Days to Decision 351 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 110d · This submission: 351d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HIT Tester, Color Vision
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1170
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.