Cleared Traditional

K802955 - MONITOR

K802955 is an FDA 510(k) clearance for MONITOR, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K802955 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Dec 1980
Decision
29d
Days
Class 2
Risk

K802955 is an FDA 510(k) clearance for the MONITOR, AIRWAY PRESSURE. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Walker, US). The FDA issued a Cleared decision on December 19, 1980 after a review of 29 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 Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K802955

510(k) Number K802955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1980
Decision Date December 19, 1980
Days to Decision 29 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
111d faster than avg
Panel avg: 140d · This submission: 29d
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 35
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K802955.
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
TRAVENOL ULTRASONIC NEBULIZER CUPS
K802054 · Travenol Laboratories, S.A. · Dec 1980
3MP-7 SCANNER RESPIRATORY MONITOR
K802565 · Bird Products Corp. · Oct 1980
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
K802090 · Draeger Medical, Inc. · Sep 1980