Cleared Traditional

K760187 - KNIFE

K760187 is the FDA 510(k) clearance for KNIFE by V. Mueller O.V. Baxter Healthcare Corp.. It is a Class 1 Ophthalmic device (product code HNN) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K760187 · V. Mueller O.V. Baxter Healthcare Corp. · Ophthalmic device
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Aug 1976
Decision
29d
Days
Class 1
Risk

K760187 is an FDA 510(k) clearance for the KNIFE, TROUTMAN CORNEAL SMALL. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1976 after a review of 29 days - a notably fast clearance cycle.

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: 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date August 04, 1976
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNN Knife, 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 - HNN Knife, Ophthalmic

All 20
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K760187.
SWAN KNIFE NEEDLE 1.5MM CAT # 1170
K791981 · Edward Weck, Inc. · Oct 1979
MICROSURGICAL KNIVES, 20, 30, 45
K781465 · Codman & Shurtleff, Inc. · Sep 1978
DISSECTOR, TROUTMAN CORNEAL
K760186 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976
KNIFE, TROUTMAN CORNEAL LARGE
K760191 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976