Cleared Traditional

K023969 - REACTIVE SKIN DECONTAMINATION LOTION (FDA 510(k) Clearance)

Class I General Hospital device.

K023969 · Dept. of the Army · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
116d
Days
Class 1
Risk

K023969 is an FDA 510(k) clearance for the REACTIVE SKIN DECONTAMINATION LOTION. Classified as Decontamination Kit (product code MAC), Class I - General Controls.

Submitted by Dept. of the Army (Fort Detrick, US). The FDA issued a Cleared decision on March 25, 2003 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4014 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Dept. of the Army devices

Submission Details

510(k) Number K023969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2002
Decision Date March 25, 2003
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 128d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MAC Decontamination Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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.