Cleared Traditional

K924192 - I.V. START KIT (AHC-50-54954 (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K924192 · American Healthcare Corp. · General & Plastic Surgery device
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Aug 1993
Decision
372d
Days
Class 1
Risk

K924192 is an FDA 510(k) clearance for the I.V. START KIT (AHC-50-54954. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by American Healthcare Corp. (South Plainfield, US). The FDA issued a Cleared decision on August 27, 1993 after a review of 372 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 American Healthcare Corp. devices

Submission Details

510(k) Number K924192 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 20, 1992
Decision Date August 27, 1993
Days to Decision 372 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
258d slower than avg
Panel avg: 114d · This submission: 372d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.