Cleared Traditional

K894455 - DECONTAMINATING KIT, SKIN: M291 (FDA 510(k) Clearance)

Class I General Hospital device.

K894455 · Dept. of the Army · General Hospital
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Aug 1989
Decision
21d
Days
Class 1
Risk

K894455 is an FDA 510(k) clearance for the DECONTAMINATING KIT, SKIN: M291. Classified as Decontamination Kit (product code MAC), Class I - General Controls.

Submitted by Dept. of the Army (Frederick, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K894455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date August 15, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 128d · This submission: 21d
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.