Cleared Traditional

K931394 - CM5000R REMOTE INDICATOR

K931394 is an FDA 510(k) clearance for CM5000R REMOTE INDICATOR, manufactured by Canadian Monaghan , Ltd.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K931394 · Canadian Monaghan , Ltd. · Anesthesiology device
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Jul 1993
Decision
104d
Days
Class 2
Risk

K931394 is an FDA 510(k) clearance for the CM5000R REMOTE INDICATOR. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Canadian Monaghan , Ltd. (London, Ontario, CA). The FDA issued a Cleared decision on July 1, 1993 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Canadian Monaghan , Ltd. devices

FDA 510(k) Submission Details - K931394

510(k) Number K931394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1993
Decision Date July 01, 1993
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 53
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K931394.
1ST RESPONSE DISPOSABLE MANOMETER
K961318 · Intertech Resources, Inc. · Dec 1996
MERCURY AIRWAY PRESSURE MANOMETER
K954486 · Mercury Medical · Apr 1996
CM7000 REMOTE INDICATOR
K931287 · Canadian Monaghan , Ltd. · Jul 1993
AIRWAY PRESSURE MONITOR CM 5000 NGAN
K925673 · Canadian Monaghan , Ltd. · Jun 1993
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990