Cleared Traditional

HYDROBRUSH (TM) KERATOME (K971078) - FDA 510(k) Clearance

Class I Ophthalmic device.

K971078 · Medjet, Inc. · Ophthalmic device
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Jan 1998
Decision
305d
Days
Class 1
Risk

K971078 is an FDA 510(k) clearance for the HYDROBRUSH (TM) KERATOME. Classified as Burr, Corneal, Ac-powered (product code HQS), Class I - General Controls.

Submitted by Medjet, Inc. (Edison, US). The FDA issued a Cleared decision on January 23, 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 886.4070 - 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 Medjet, Inc. devices

Submission Details

510(k) Number K971078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date January 23, 1998
Days to Decision 305 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
195d slower than avg
Panel avg: 110d · This submission: 305d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQS Burr, Corneal, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4070
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.