Cleared Traditional

K872625 - DECALCIFYING SOLUTION

K872625 is an FDA 510(k) clearance for DECALCIFYING SOLUTION, manufactured by Stephens Scientific. The device is a Class 1 Pathology device with product code KDX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K872625 · Stephens Scientific · Pathology device
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Aug 1987
Decision
31d
Days
Class 1
Risk

K872625 is an FDA 510(k) clearance for the DECALCIFYING SOLUTION. Classified as Solution, Decalcifier, Acid Containing (product code KDX), Class I - General Controls.

Submitted by Stephens Scientific (Denville, US). The FDA issued a Cleared decision on August 6, 1987 after a review of 31 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 Stephens Scientific devices

FDA 510(k) Submission Details - K872625

510(k) Number K872625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date August 06, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 77d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

KDX Device Classification - Class 1, General Controls

Product Code KDX Solution, Decalcifier, Acid Containing
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 - KDX Solution, Decalcifier, Acid Containing

Devices cleared under the same product code (KDX) and FDA review panel - the closest regulatory comparables to K872625.
SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E
K850636 · Fisher Scientific Co., LLC · Mar 1985
DECALCIFIER SOLUTION
K842726 · E K Ind., Inc. · Aug 1984
DECALCIFIER I
K841488 · Surgipath Medical Industries, Inc. · May 1984
VOLU-SOL DECALCIFER
K822036 · Volu Sol Medical Industries · Aug 1982
CAL-RITE
K811801 · Richard-Allan Medical Ind., Inc. · Jul 1981