Cleared Traditional

K791241 - BRIOX MODEL 2000-CA COMPRESSOR UNIT

K791241 is the FDA 510(k) clearance for BRIOX MODEL 2000-CA COMPRESSOR UNIT by Briox Technologies, Inc.. It is a Class 2 General & Plastic Surgery device (product code JCX) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K791241 · Briox Technologies, Inc. · General & Plastic Surgery device
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Jul 1979
Decision
18d
Days
Class 2
Risk

K791241 is an FDA 510(k) clearance for the BRIOX MODEL 2000-CA COMPRESSOR UNIT. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Briox Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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 Briox Technologies, Inc. devices

Submission Details

510(k) Number K791241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1979
Decision Date July 24, 1979
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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.