Cleared Traditional

K821649 - MONAGHAN'S PRESSURE ALARM

K821649 is an FDA 510(k) clearance for MONAGHAN'S PRESSURE ALARM, manufactured by Monaghan Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K821649 · Monaghan Medical Corp. · Anesthesiology device
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Aug 1982
Decision
62d
Days
Class 2
Risk

K821649 is an FDA 510(k) clearance for the MONAGHAN'S PRESSURE ALARM. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on August 5, 1982 after a review of 62 days - a notably fast clearance 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: 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K821649

510(k) Number K821649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1982
Decision Date August 05, 1982
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 140d · This submission: 62d
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 32
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K821649.
AIRWAY PRESSURE MONITOR
K840420 · Respiratory Support Products, Inc. · Apr 1984
DRAGER BAROMED
K840279 · Draeger Medical, Inc. · Mar 1984
EMERSON MODEL 3MV-AP AND 3V-AP PRESS-
K832271 · J. H. Emerson Co. · Sep 1983
SINGLE USE NON-CONDUCTIVE CIRC. DISCON
K821667 · Vital Signs, Inc. · Jun 1982
BIRD MEAN AIRWAY PRESSURE MONITOR
K812140 · 3M Company · Aug 1981
AIRWAY PRESSURE MONITOR
K810753 · Impact Instrumentation, Inc. · Mar 1981