Cleared Traditional

K810255 - MEAN PRESSURE MONITOR

K810255 is the FDA 510(k) clearance for MEAN PRESSURE MONITOR by Healthdyne, Inc.. It is a Class 2 Anesthesiology device (product code CAP) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810255 · Healthdyne, Inc. · Anesthesiology device
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Feb 1981
Decision
13d
Days
Class 2
Risk

K810255 is an FDA 510(k) clearance for the MEAN PRESSURE MONITOR. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1981 after a review of 13 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 Healthdyne, Inc. devices

Submission Details

510(k) Number K810255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1981
Decision Date February 12, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K810255.
DRAGER BAROMED
K840279 · Draeger Medical, Inc. · Mar 1984
SINGLE USE NON-CONDUCTIVE CIRC. DISCON
K821667 · Vital Signs, Inc. · Jun 1982
BIRD MEAN AIRWAY PRESSURE MONITOR
K812140 · 3M Company · Aug 1981
TRAVENOL ULTRASONIC NEBULIZER CUPS
K802054 · Travenol Laboratories, S.A. · Dec 1980
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
K802090 · Draeger Medical, Inc. · Sep 1980