Cleared Traditional

K883848 - KMI OXY-BAN

K883848 is an FDA 510(k) clearance for KMI OXY-BAN, manufactured by Knight Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K883848 · Knight Medical, Inc. · General & Plastic Surgery device
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Mar 1989
Decision
171d
Days
Class 2
Risk

K883848 is an FDA 510(k) clearance for the KMI OXY-BAN. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Knight Medical, Inc. (Houston, US). The FDA issued a Cleared decision on March 2, 1989 after a review of 171 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5650 - 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 Knight Medical, Inc. devices

FDA 510(k) Submission Details - K883848

510(k) Number K883848 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 12, 1988
Decision Date March 02, 1989
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPJ Device Classification - Class 2, Special Controls

Product Code KPJ Chamber, Oxygen, Topical, Extremity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KPJ Chamber, Oxygen, Topical, Extremity

Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K883848.
Wound Treatment System (VHT-200)
K250188 · Vaporox, Inc. · Mar 2025
VHT-200 Wound Treatment System
K212121 · Vaporox, Inc. · Mar 2023
EPIFLO-28
K190742 · Neogenix, LLC Dba Ogenix · Dec 2019
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K840817 · Hospitak, Inc. · Apr 1984
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
K831825 · Hospitak, Inc. · Oct 1983