Cleared Traditional

K853497 - PREFILLED SPECIMEN JARS 10% NEUTRAL BUF...

K853497 is the FDA 510(k) clearance for PREFILLED SPECIMEN JARS 10% NEUTRAL BUF... by Surgipath Medical Industries, Inc.. It is a Class 1 Pathology device (product code IFP) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K853497 · Surgipath Medical Industries, Inc. · Pathology device
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Aug 1985
Decision
8d
Days
Class 1
Risk

K853497 is an FDA 510(k) clearance for the PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN. Classified as Formalin, Neutral Buffered (product code IFP), Class I - General Controls.

Submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on August 28, 1985 after a review of 8 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 Surgipath Medical Industries, Inc. devices

Submission Details

510(k) Number K853497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date August 28, 1985
Days to Decision 8 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 77d · This submission: 8d
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.

Regulatory Peers - IFP Formalin, Neutral Buffered

Devices cleared under the same product code (IFP) and FDA review panel - the closest regulatory comparables to K853497.
(MSI) PATH-SAVER
K872140 · Medical Specialties, Inc. · Jun 1987
BUF-FIX
K842728 · E K Ind., Inc. · Aug 1984
FORMALIN SOLUTION 10% NEUTRAL BUFFER
K840926 · Sigma Chemical Co. · Mar 1984
NEUTRAL DUFFERED FORMA-SCENT
K812817 · Meridian Diagnostics, Inc. · Nov 1981
10% NEUTRAL BUFFERED FORMALDEHYDE
K811795 · Richard-Allan Medical Ind., Inc. · Jul 1981