Cleared Traditional

K964029 - EMERGENCY RELIEF KIT SYSTEM

K964029 · Baxter Healthcare Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
161d
Days
-
Risk

K964029 is an FDA 510(k) clearance for the EMERGENCY RELIEF KIT SYSTEM. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 17, 1997 after a review of 161 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K964029

510(k) Number K964029 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 07, 1996
Decision Date March 17, 1997
Days to Decision 161 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 115d · This submission: 161d
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 K964029.
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