Cleared Traditional

K971078 - HYDROBRUSH (TM) KERATOME

K971078 is an FDA 510(k) clearance for HYDROBRUSH (TM) KERATOME, manufactured by Medjet, Inc.. The device is a Class 1 Ophthalmic device with product code HQS cleared through the Traditional 510(k) pathway after a 305-day FDA review.

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

FDA 510(k) Submission Details - K971078

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 110d · This submission: 305d
Pathway characteristics
Predicate-based equivalence.

HQS Device Classification - Class 1, General Controls

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.