Cleared Traditional

K792356 - OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR

K792356 is the FDA 510(k) clearance for OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR by Oxequip Health Ind.. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K792356 · Oxequip Health Ind. · Anesthesiology device
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Dec 1979
Decision
13d
Days
Class 2
Risk

K792356 is an FDA 510(k) clearance for the OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Oxequip Health Ind. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1979 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - the FDA anesthesiology and respiratory 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 Oxequip Health Ind. devices

Submission Details

510(k) Number K792356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1979
Decision Date December 04, 1979
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 Anesthesiology devices follow this clearance model.