Cleared Traditional

K884755 - CONSED FECAL CONCENTRATION SYSTEM

K884755 is an FDA 510(k) clearance for CONSED FECAL CONCENTRATION SYSTEM, manufactured by Donald L. Price, Ph.D.. The device is a Class 1 Pathology device with product code IFP cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K884755 · Donald L. Price, Ph.D. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K884755

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
21d faster than avg
Panel avg: 78d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

IFP Device Classification - Class 1, General Controls

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.

Regulatory Peers - IFP Formalin, Neutral Buffered

All 10
Devices cleared under the same product code (IFP) and FDA review panel - the closest regulatory comparables to K884755.
(MSI) PATH-SAVER
K872140 · Medical Specialties, Inc. · Jun 1987
PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN
K853497 · Surgipath Medical Industries, Inc. · Aug 1985
FORMALIN BUFFERED
K842982 · Reagent Laboratory, Inc. · Oct 1984
BUF-FIX
K842728 · E K Ind., Inc. · Aug 1984
FORMALIN SOLUTION 10% NEUTRAL BUFFER
K840926 · Sigma Chemical Co. · Mar 1984
MILLONIG'S MODIFIED PHOSPHATE BUFFERED
K830582 · Surgipath Medical Industries, Inc. · Mar 1983