Cleared Traditional

K940249 - CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING

K940249 · Certified Safety Mfg., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
257d
Days
-
Risk

K940249 is an FDA 510(k) clearance for the CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 257 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.

View all Certified Safety Mfg., Inc. devices

FDA 510(k) Submission Details - K940249

510(k) Number K940249 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 19, 1994
Decision Date October 03, 1994
Days to Decision 257 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 115d · This submission: 257d
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 K940249.
EMERGENCY RELIEF KIT SYSTEM
K964029 · Baxter Healthcare Corp · Mar 1997
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