Cleared Traditional

SHAWNEE PRODUCTS KIT I (K921762) - FDA 510(k) Clearance

K921762 · Absentee Shawnee Bandage Group · General & Plastic Surgery device
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Jan 1993
Decision
267d
Days
-
Risk

K921762 is an FDA 510(k) clearance for the SHAWNEE PRODUCTS KIT I. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Absentee Shawnee Bandage Group (Tecumseh, US). The FDA issued a Cleared decision on January 6, 1993 after a review of 267 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 Absentee Shawnee Bandage Group devices

Submission Details

510(k) Number K921762 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 14, 1992
Decision Date January 06, 1993
Days to Decision 267 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
152d slower than avg
Panel avg: 115d · This submission: 267d
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.