Cleared Traditional

K850636 - SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E

K850636 is an FDA 510(k) clearance for SIMUTANEOUS FIXATION & DECALCIFYING SOL..., manufactured by Fisher Scientific Co., LLC. The device is a Class 1 Pathology device with product code KDX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K850636 · Fisher Scientific Co., LLC · Pathology device
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Mar 1985
Decision
29d
Days
Class 1
Risk

K850636 is an FDA 510(k) clearance for the SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E. Classified as Solution, Decalcifier, Acid Containing (product code KDX), Class I - General Controls.

Submitted by Fisher Scientific Co., LLC (Fair Lawn, US). The FDA issued a Cleared decision on March 20, 1985 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 Fisher Scientific Co., LLC devices

FDA 510(k) Submission Details - K850636

510(k) Number K850636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date March 20, 1985
Days to Decision 29 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
48d faster than avg
Panel avg: 77d · This submission: 29d
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.