Cleared Traditional

K903001 - SLIMCATH (TM)

K903001 is an FDA 510(k) clearance for SLIMCATH (TM), manufactured by Gynopharma, Inc.. The device is a Class 1 Ophthalmic device with product code HIT cleared through the Traditional 510(k) pathway after a 351-day FDA review.

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

FDA 510(k) Submission Details - K903001

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.

HIT Device Classification - Class 1, General Controls

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.