Cleared Traditional

K872140 - (MSI) PATH-SAVER

K872140 is an FDA 510(k) clearance for (MSI) PATH-SAVER, manufactured by Medical Specialties, Inc.. The device is a Class 1 Pathology device with product code IFP cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K872140 · Medical Specialties, Inc. · Pathology device
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Jun 1987
Decision
13d
Days
Class 1
Risk

K872140 is an FDA 510(k) clearance for the (MSI) PATH-SAVER. Classified as Formalin, Neutral Buffered (product code IFP), Class I - General Controls.

Submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on June 15, 1987 after a review of 13 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 Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K872140

510(k) Number K872140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1987
Decision Date June 15, 1987
Days to Decision 13 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 77d · This submission: 13d
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 9
Devices cleared under the same product code (IFP) and FDA review panel - the closest regulatory comparables to K872140.
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
NEUTRAL BUFFERED FORMALIN 10%
K830583 · Surgipath Medical Industries, Inc. · Mar 1983