Cleared Traditional

K935342 - SCMD KERATOME

K935342 is an FDA 510(k) clearance for SCMD KERATOME, manufactured by S.C.M.D. Keratomes of Arizona. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K935342 · S.C.M.D. Keratomes of Arizona · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
147d
Days
Class 1
Risk

K935342 is an FDA 510(k) clearance for the SCMD KERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by S.C.M.D. Keratomes of Arizona (Ftn. Hills, US). The FDA issued a Cleared decision on April 1, 1994 after a review of 147 days - within the typical 510(k) review window.

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: 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 S.C.M.D. Keratomes of Arizona devices

FDA 510(k) Submission Details - K935342

510(k) Number K935342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1993
Decision Date April 01, 1994
Days to Decision 147 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 110d · This submission: 147d
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 K935342.
ML MICROKERATOME BLADE
K962661 · Med-Logics, Inc. · Dec 1996
PLANCON MIRCOLAMELLAR KERATOME
K960395 · Plancon Instruments · Apr 1996
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · Chiron Vision Corp. · Nov 1994
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · Storz Instrument Co. · Jan 1991
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
K870807 · Allergan, Inc. · May 1987