Cleared Traditional

K861593 - TOPICAL HYPERBARIC OXYGEN CHAMBER

K861593 is an FDA 510(k) clearance for TOPICAL HYPERBARIC OXYGEN CHAMBER, manufactured by Stephenson Industries, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K861593 · Stephenson Industries, Inc. · General & Plastic Surgery device
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May 1986
Decision
13d
Days
Class 2
Risk

K861593 is an FDA 510(k) clearance for the TOPICAL HYPERBARIC OXYGEN CHAMBER. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Stephenson Industries, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 12, 1986 after a review of 13 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stephenson Industries, Inc. devices

FDA 510(k) Submission Details - K861593

510(k) Number K861593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 12, 1986
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
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

All 12
Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K861593.
LIFETECH CASSETTE
K960756 · Lifetech Systems, Inc. · Aug 1997
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
K963777 · Stephenson Industries, Inc. · Jul 1997
O2 CARE
K882461 · Ballard Medical Products · Nov 1988
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K840817 · Hospitak, Inc. · Apr 1984
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
K831825 · Hospitak, Inc. · Oct 1983