Cleared Traditional

K903912 - KERATOME

K903912 is an FDA 510(k) clearance for KERATOME, manufactured by Micro Precision Instrument Co.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K903912 · Micro Precision Instrument Co. · Ophthalmic device
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Oct 1990
Decision
54d
Days
Class 1
Risk

K903912 is an FDA 510(k) clearance for the KERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Micro Precision Instrument Co. (Scottsdale, US). The FDA issued a Cleared decision on October 17, 1990 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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 Micro Precision Instrument Co. devices

FDA 510(k) Submission Details - K903912

510(k) Number K903912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1990
Decision Date October 17, 1990
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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 - HNO Keratome, Ac-powered

All 60
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K903912.
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K860001 · American Medical Optics · Feb 1986