Cleared Traditional

K972727 - CBALK-1000 BLADE

K972727 is an FDA 510(k) clearance for CBALK-1000 BLADE, manufactured by Howard Instruments, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K972727 · Howard Instruments, Inc. · Ophthalmic device
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Oct 1997
Decision
81d
Days
Class 1
Risk

K972727 is an FDA 510(k) clearance for the CBALK-1000 BLADE. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Howard Instruments, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on October 10, 1997 after a review of 81 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 Howard Instruments, Inc. devices

FDA 510(k) Submission Details - K972727

510(k) Number K972727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1997
Decision Date October 10, 1997
Days to Decision 81 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
29d faster than avg
Panel avg: 110d · This submission: 81d
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 41
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K972727.
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K941550 · Chiron Vision Corp. · Nov 1994