Cleared Traditional

ALTA DRESSING FRAME (K926380) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K926380 · Alta Medical Products, Inc. · General & Plastic Surgery device
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Aug 1993
Decision
227d
Days
Class 1
Risk

K926380 is an FDA 510(k) clearance for the ALTA DRESSING FRAME. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Alta Medical Products, Inc. (Sandy, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 227 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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. 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 Alta Medical Products, Inc. devices

Submission Details

510(k) Number K926380 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 22, 1992
Decision Date August 06, 1993
Days to Decision 227 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
112d slower than avg
Panel avg: 115d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 16
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K926380.
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982
DRESSING, ENVIRON WOUND
K782008 · Abbott Laboratories · May 1979
HYDRON BURN BANDAGE MANUAL APPLICATION
K781406 · Abbott Laboratories · Sep 1978