Cleared Traditional

K952561 - WATER JEL BURN KIT

K952561 · Water-Jel Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K952561

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.

LRR Device Classification - Class 0,

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.

Regulatory Peers - LRR First Aid Kit With Drug

Devices cleared under the same product code (LRR) and FDA review panel - the closest regulatory comparables to K952561.
EMERGENCY RELIEF KIT SYSTEM
K964029 · Baxter Healthcare Corp · Mar 1997
CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
K940249 · Certified Safety Mfg., Inc. · Oct 1994
FIRST AID/TRUMA KIT
K941311 · Certified Safety Mfg., Inc. · Jun 1994
FIRST AID KIT, VARIOUS SIZES
K871376 · Fraass Survival Systems, Inc. · Jun 1987
KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE
K871501 · Fraass Survival Systems, Inc. · Jun 1987
FIRST AID KIT, EYE DRESSING
K871457 · Fraass Survival Systems, Inc. · May 1987