Cleared Traditional

TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER (K920948) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920948 · Topox Therapeuutic Rentals, Inc. · General & Plastic Surgery device
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Aug 1992
Decision
162d
Days
Class 2
Risk

K920948 is an FDA 510(k) clearance for the TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Topox Therapeuutic Rentals, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 11, 1992 after a review of 162 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 Topox Therapeuutic Rentals, Inc. devices

Submission Details

510(k) Number K920948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date August 11, 1992
Days to Decision 162 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
47d slower than avg
Panel avg: 115d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.