Cleared Traditional

K941793 - OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)

K941793 is an FDA 510(k) clearance for OXYGEN CONCENTRATION STATUS INDICATOR (..., manufactured by Mountain Medical Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 436-day FDA review.

K941793 · Mountain Medical Equipment, Inc. · Anesthesiology device
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Jun 1995
Decision
436d
Days
Class 2
Risk

K941793 is an FDA 510(k) clearance for the OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.). Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Mountain Medical Equipment, Inc. (Littleton, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 436 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Mountain Medical Equipment, Inc. devices

FDA 510(k) Submission Details - K941793

510(k) Number K941793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date June 21, 1995
Days to Decision 436 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 140d · This submission: 436d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 82
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K941793.
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K944654 · Aequitron Medical, Inc. · Nov 1994
MINIOX 1000 OXYGEN CONCENTRATION INDICATOR
K935364 · Minesafety Appliances Co. · Jun 1994
PRO2 OXYGEN ANALYZER
K922438 · Martech Medical Products, Inc. · Mar 1993