Cleared Traditional

K940768 - AD PERFECT (FDA 510(k) Clearance)

Class I Pathology device.

K940768 · Chimera Research & Chemical, Inc. · Pathology device
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Feb 1995
Decision
364d
Days
Class 1
Risk

K940768 is an FDA 510(k) clearance for the AD PERFECT. Classified as Glutaraldehyde (product code IFT), Class I - General Controls.

Submitted by Chimera Research & Chemical, Inc. (Seminole, US). The FDA issued a Cleared decision on February 17, 1995 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chimera Research & Chemical, Inc. devices

Submission Details

510(k) Number K940768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date February 17, 1995
Days to Decision 364 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 77d · This submission: 364d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IFT Glutaraldehyde
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.