Cleared Traditional

K904845 - STORZ DRAEGER ROTOR KERATOME

K904845 is an FDA 510(k) clearance for STORZ DRAEGER ROTOR KERATOME, manufactured by Storz Instrument Co.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K904845 · Storz Instrument Co. · Ophthalmic device
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Jan 1991
Decision
89d
Days
Class 1
Risk

K904845 is an FDA 510(k) clearance for the STORZ DRAEGER ROTOR KERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on January 22, 1991 after a review of 89 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 Storz Instrument Co. devices

FDA 510(k) Submission Details - K904845

510(k) Number K904845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1990
Decision Date January 22, 1991
Days to Decision 89 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
21d faster than avg
Panel avg: 110d · This submission: 89d
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 14
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K904845.
HANSATOME MICROKERATOME
K972808 · Chiron Vision Corp. · Oct 1997
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · Chiron Vision Corp. · Nov 1994
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
K870807 · Allergan, Inc. · May 1987
BKS-42 DISPOSABLE VACUUM TUBING PACK
K864065 · Allergan, Inc. · Dec 1986
ELECTRO-KERATOTOME, LINE-OPERATED
K760726 · Storz Instrument Co. · Oct 1976