Cleared Traditional

VARIOUS KITS (K931634) - FDA 510(k) Clearance

K931634 · Polymint Industrial Co. , Ltd. · General & Plastic Surgery device
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Nov 1993
Decision
243d
Days
-
Risk

K931634 is an FDA 510(k) clearance for the VARIOUS KITS. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Polymint Industrial Co. , Ltd. (Golden,, US). The FDA issued a Cleared decision on November 30, 1993 after a review of 243 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 Polymint Industrial Co. , Ltd. devices

Submission Details

510(k) Number K931634 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 01, 1993
Decision Date November 30, 1993
Days to Decision 243 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 115d · This submission: 243d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.