Cleared Traditional

K925335 - ACUFEX INTRA ARTICULAR MEASURING DEVICE (FDA 510(k) Clearance)

Class I Orthopedic device.

K925335 · Acufex Microsurgical, Inc. · Orthopedic device
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Dec 1992
Decision
68d
Days
Class 1
Risk

K925335 is an FDA 510(k) clearance for the ACUFEX INTRA ARTICULAR MEASURING DEVICE. Classified as Gauge, Depth (product code HTJ), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on December 29, 1992 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4300 - the FDA orthopedic device regulatory 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K925335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date December 29, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTJ Gauge, Depth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4300
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.