Cleared Traditional

K884755 - CONSED FECAL CONCENTRATION SYSTEM (FDA 510(k) Clearance)

Class I Pathology device.

K884755 · Donald L. Price, Ph.D. · Pathology device
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Jan 1989
Decision
57d
Days
Class 1
Risk

K884755 is an FDA 510(k) clearance for the CONSED FECAL CONCENTRATION SYSTEM. Classified as Formalin, Neutral Buffered (product code IFP), Class I - General Controls.

Submitted by Donald L. Price, Ph.D. (Bradenton, US). The FDA issued a Cleared decision on January 10, 1989 after a review of 57 days - a notably fast clearance cycle.

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: 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 Donald L. Price, Ph.D. devices

Submission Details

510(k) Number K884755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date January 10, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 77d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IFP Formalin, Neutral Buffered
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.