Cleared Traditional

K812587 - MONO 2 OXYGEN MONITOR

K812587 is an FDA 510(k) clearance for MONO 2 OXYGEN MONITOR, manufactured by Kantron Cardiovascular, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K812587 · Kantron Cardiovascular, Inc. · Anesthesiology device
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Oct 1981
Decision
25d
Days
Class 2
Risk

K812587 is an FDA 510(k) clearance for the MONO 2 OXYGEN MONITOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Kantron Cardiovascular, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981 after a review of 25 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 Kantron Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K812587

510(k) Number K812587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1981
Decision Date October 06, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
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 76
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K812587.
YSI #2600 MULTI-CHANNEL DUAL-DISPLAY
K823231 · Yellow Springs Instrument Co., Inc. · Dec 1982
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP
K823232 · Yellow Springs Instrument Co., Inc. · Dec 1982
MK 808 SERIES NASAL OXYGEN SAMPLER
K822608 · Instrumentation Industries, Inc. · Oct 1982
NEOCARE OXYGEN MONITOR
K810571 · Vickers America Medical Corp. · Mar 1981
MONITOR, OXYCHEK OXYGEN
K782114 · Critikon Company, LLC · Jan 1979
ANALYZER, OXYGEN, MODEL OM-92
K771028 · Cavitron Corp. · Jul 1977