Cleared Traditional

WATER JEL BURN KIT (K952561) - FDA 510(k) Clearance

K952561 · Water-Jel Technologies, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
42d
Days
-
Risk

K952561 is an FDA 510(k) clearance for the WATER JEL BURN KIT. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Water-Jel Technologies, Inc. (Carlstadt, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Water-Jel Technologies, Inc. devices

Submission Details

510(k) Number K952561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date July 14, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRR First Aid Kit With Drug
Device Class -
Definition Note: In Addition To Compliance With Our Convenience Kit Guidance, In Regards To Any Drug Products Contained In This Kit Compliance With The Center For Drug Evaluation Is Required As Well. Www.fda.gov/cder/index.html - This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. 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.