Cleared Traditional

K852424 - ACUFEX COMPARATIVE SURGICAL KERATOMETER

K852424 is an FDA 510(k) clearance for ACUFEX COMPARATIVE SURGICAL KERATOMETER, manufactured by Acufex Microsurgical, Inc.. The device is a Class 1 Ophthalmic device with product code HJB cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K852424 · Acufex Microsurgical, Inc. · Ophthalmic device
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Sep 1985
Decision
96d
Days
Class 1
Risk

K852424 is an FDA 510(k) clearance for the ACUFEX COMPARATIVE SURGICAL KERATOMETER. Classified as Instrument, Measuring, Corneal Radius (product code HJB), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Norwood, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1450 - 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. Standard predicate reliance. 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 Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K852424

510(k) Number K852424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1985
Decision Date September 11, 1985
Days to Decision 96 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
14d faster than avg
Panel avg: 110d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

HJB Device Classification - Class 1, General Controls

Product Code HJB Instrument, Measuring, Corneal Radius
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1450
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.