Cleared Traditional

K871376 - FIRST AID KIT, VARIOUS SIZES

K871376 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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Jun 1987
Decision
58d
Days
-
Risk

K871376 is an FDA 510(k) clearance for the FIRST AID KIT, VARIOUS SIZES. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Fraass Survival Systems, Inc. (Bronx, US). The FDA issued a Cleared decision on June 4, 1987 after a review of 58 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 Fraass Survival Systems, Inc. devices

FDA 510(k) Submission Details - K871376

510(k) Number K871376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 07, 1987
Decision Date June 04, 1987
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
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 K871376.
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
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