Cleared Traditional

K812140 - BIRD MEAN AIRWAY PRESSURE MONITOR

K812140 is an FDA 510(k) clearance for BIRD MEAN AIRWAY PRESSURE MONITOR, manufactured by 3M Company. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812140 · 3M Company · Anesthesiology device
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Aug 1981
Decision
23d
Days
Class 2
Risk

K812140 is an FDA 510(k) clearance for the BIRD MEAN AIRWAY PRESSURE MONITOR. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by 3M Company (Monrovia, US). The FDA issued a Cleared decision on August 20, 1981 after a review of 23 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 3M Company devices

FDA 510(k) Submission Details - K812140

510(k) Number K812140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date August 20, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 140d · This submission: 23d
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 40
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K812140.
EMERSON MODEL 3MV-AP AND 3V-AP PRESS-
K832271 · J. H. Emerson Co. · Sep 1983
MONAGHAN'S PRESSURE ALARM
K821649 · Monaghan Medical Corp. · Aug 1982
SINGLE USE NON-CONDUCTIVE CIRC. DISCON
K821667 · Vital Signs, Inc. · Jun 1982
AIRWAY PRESSURE MONITOR
K810753 · Impact Instrumentation, Inc. · Mar 1981
SECHRIST AIRWAY PRESSURE MONITOR #400
K810648 · Sechrist Industries, Inc. · Mar 1981
MEAN PRESSURE MONITOR
K810255 · Healthdyne, Inc. · Feb 1981