Cleared Traditional

K925673 - AIRWAY PRESSURE MONITOR CM 5000 NGAN

K925673 is an FDA 510(k) clearance for AIRWAY PRESSURE MONITOR CM 5000 NGAN, 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 211-day FDA review.

K925673 · Canadian Monaghan , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
211d
Days
Class 2
Risk

K925673 is an FDA 510(k) clearance for the AIRWAY PRESSURE MONITOR CM 5000 NGAN. 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 June 9, 1993 after a review of 211 days - an extended review cycle.

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 - K925673

510(k) Number K925673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date June 09, 1993
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 140d · This submission: 211d
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 K925673.
MERCURY AIRWAY PRESSURE MANOMETER
K954486 · Mercury Medical · Apr 1996
CM7000 REMOTE INDICATOR
K931287 · Canadian Monaghan , Ltd. · Jul 1993
CM5000R REMOTE INDICATOR
K931394 · Canadian Monaghan , Ltd. · Jul 1993
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990
INFANT C.P.A.P. MONITOR
K896136 · Hudson Oxygen Therapy Sales Co. · Jan 1990