Cleared Traditional

K872663 - DRY-FORM

K872663 is the FDA 510(k) clearance for DRY-FORM by Anatech, Ltd.. It is a Class 1 Pathology device (product code IFP) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K872663 · Anatech, Ltd. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
29d
Days
Class 1
Risk

K872663 is an FDA 510(k) clearance for the DRY-FORM. Classified as Formalin, Neutral Buffered (product code IFP), Class I - General Controls.

Submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on August 6, 1987 after a review of 29 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 Anatech, Ltd. devices

Submission Details

510(k) Number K872663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1987
Decision Date August 06, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 77d · This submission: 29d
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 K872663.
(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