Cleared Traditional

K921761 - SHAWNEE PRODUCTS KIT II

K921761 is an FDA 510(k) clearance for SHAWNEE PRODUCTS KIT II, manufactured by Absentee Shawnee Bandage Group. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K921761 · Absentee Shawnee Bandage Group · General & Plastic Surgery device
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Mar 1993
Decision
338d
Days
Class 1
Risk

K921761 is an FDA 510(k) clearance for the SHAWNEE PRODUCTS KIT II. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Absentee Shawnee Bandage Group (Tecumseh, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K921761

510(k) Number K921761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 14, 1992
Decision Date March 18, 1993
Days to Decision 338 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
223d slower than avg
Panel avg: 115d · This submission: 338d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGX Tape And Bandage, Adhesive

All 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K921761.
TISSUE ISOLATION AND RETRIEVAL BAG
K931886 · Advanced Surgical, Inc. · Sep 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · Johnson & Johnson Medical, Inc. · May 1993
ISOPORE(TM) TAPE, MODIFICATION
K925384 · Lectec Corp. · Apr 1993
STRAPPAL
K922897 · Smith & Nephew United, Inc. · Sep 1992
ISOPORE TAPE
K922959 · Lectec Corp. · Sep 1992
LUEKOFLEX SURGICAL TAPE
K923404 · Beiersdorf, Inc. · Sep 1992