Cleared Traditional

K980675 - SUMMIT KRUMEICH-BARRAQUER MICROKERATOME

K980675 is an FDA 510(k) clearance for SUMMIT KRUMEICH-BARRAQUER MICROKERATOME, manufactured by Summit Technology, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K980675 · Summit Technology, Inc. · Ophthalmic device
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Dec 1998
Decision
305d
Days
Class 1
Risk

K980675 is an FDA 510(k) clearance for the SUMMIT KRUMEICH-BARRAQUER MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Summit Technology, Inc. (Waltham, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Summit Technology, Inc. devices

FDA 510(k) Submission Details - K980675

510(k) Number K980675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1998
Decision Date December 22, 1998
Days to Decision 305 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 110d · This submission: 305d
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 15
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K980675.
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K972808 · Chiron Vision Corp. · Oct 1997
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K941550 · Chiron Vision Corp. · Nov 1994
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991