Cleared Traditional

K871337 - M-2 OXYGEN/TEMPERATURE MONITOR

K871337 is an FDA 510(k) clearance for M-2 OXYGEN/TEMPERATURE MONITOR, manufactured by Bio-Med Devices, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K871337 · Bio-Med Devices, Inc. · Anesthesiology device
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Jun 1987
Decision
63d
Days
Class 2
Risk

K871337 is an FDA 510(k) clearance for the M-2 OXYGEN/TEMPERATURE MONITOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Bio-Med Devices, Inc. (Madison, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 63 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 Bio-Med Devices, Inc. devices

FDA 510(k) Submission Details - K871337

510(k) Number K871337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1987
Decision Date June 05, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 140d · This submission: 63d
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 43
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K871337.
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
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