Cleared Traditional

K812940 - 10% NEUTRAL BUFFERED FORMALIN CONCENT

K812940 is the FDA 510(k) clearance for 10% NEUTRAL BUFFERED FORMALIN CONCENT by Surgipath. It is a Class 1 Pathology device (product code IFP) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K812940 · Surgipath · Pathology device
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Dec 1981
Decision
51d
Days
Class 1
Risk

K812940 is an FDA 510(k) clearance for the 10% NEUTRAL BUFFERED FORMALIN CONCENT. Classified as Formalin, Neutral Buffered (product code IFP), Class I - General Controls.

Submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on December 10, 1981 after a review of 51 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 devices

Submission Details

510(k) Number K812940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1981
Decision Date December 10, 1981
Days to Decision 51 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 77d · This submission: 51d
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

All 9
Devices cleared under the same product code (IFP) and FDA review panel - the closest regulatory comparables to K812940.
MILLONIG'S MODIFIED PHOSPHATE BUFFERED
K830582 · Surgipath Medical Industries, Inc. · Mar 1983
NEUTRAL BUFFERED FORMALIN 10%
K830583 · Surgipath Medical Industries, Inc. · Mar 1983
MILLONIGS MODIFIED PHOSPHATE BUFFERED
K830514 · Surgipath Medical Industries, Inc. · Mar 1983
NEUTRAL DUFFERED FORMA-SCENT
K812817 · Meridian Diagnostics, Inc. · Nov 1981
10% NEUTRAL BUFFERED FORMALDEHYDE
K811795 · Richard-Allan Medical Ind., Inc. · Jul 1981