Cleared Traditional

K882268 - ZINC FORMALIN CONCENTRATE

K882268 is an FDA 510(k) clearance for ZINC FORMALIN CONCENTRATE, manufactured by Anatech, Ltd.. The device is a Class 1 Pathology device with product code IGG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K882268 · Anatech, Ltd. · Pathology device
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Jun 1988
Decision
15d
Days
Class 1
Risk

K882268 is an FDA 510(k) clearance for the ZINC FORMALIN CONCENTRATE. Classified as Formaldehyde (formalin, Formol) (product code IGG), Class I - General Controls.

Submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on June 15, 1988 after a review of 15 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 - K882268

510(k) Number K882268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date June 15, 1988
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 78d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

IGG Device Classification - Class 1, General Controls

Product Code IGG Formaldehyde (formalin, Formol)
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 - IGG Formaldehyde (formalin, Formol)

Devices cleared under the same product code (IGG) and FDA review panel - the closest regulatory comparables to K882268.
FORMALDEHYDE SOLUTION, 37%
K861201 · Surgipath Medical Industries, Inc. · Apr 1986
37% FORMALDEHYDE
K811794 · Richard-Allan Medical Ind., Inc. · Jul 1981
PLEASCENT OR FORMA-SCENT
K802506 · Meridian Diagnostics, Inc. · Nov 1980
PARA-PAK FORMALIN
K792705 · Meridian Diagnostics, Inc. · Jan 1980
PARA-PAK SAF
K792707 · Meridian Diagnostics, Inc. · Jan 1980