Cleared Traditional

K882461 - O2 CARE

K882461 is an FDA 510(k) clearance for O2 CARE, manufactured by Ballard Medical Products. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K882461 · Ballard Medical Products · General & Plastic Surgery device
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Nov 1988
Decision
166d
Days
Class 2
Risk

K882461 is an FDA 510(k) clearance for the O2 CARE. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Ballard Medical Products (Midvale, US). The FDA issued a Cleared decision on November 28, 1988 after a review of 166 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 Ballard Medical Products devices

FDA 510(k) Submission Details - K882461

510(k) Number K882461 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 15, 1988
Decision Date November 28, 1988
Days to Decision 166 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 115d · This submission: 166d
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 K882461.
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