Cleared Traditional

K891483 - FIRST AID SURVIVAL KIT

K891483 · Elwyn, Inc. · General & Plastic Surgery device
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May 1989
Decision
55d
Days
-
Risk

K891483 is an FDA 510(k) clearance for the FIRST AID SURVIVAL KIT. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Elwyn, Inc. (Elwyn, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 55 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 Elwyn, Inc. devices

FDA 510(k) Submission Details - K891483

510(k) Number K891483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date May 11, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
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 K891483.
EMERGENCY RELIEF KIT SYSTEM
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K871376 · Fraass Survival Systems, Inc. · Jun 1987
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K871501 · Fraass Survival Systems, Inc. · Jun 1987
FIRST AID KIT, EYE DRESSING
K871457 · Fraass Survival Systems, Inc. · May 1987