Cleared Traditional

K812046 - TIDAL VOLUME MONITOR 150

K812046 is an FDA 510(k) clearance for TIDAL VOLUME MONITOR 150, manufactured by Medix Medical Electronics (U.S.A.), Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K812046 · Medix Medical Electronics (U.S.A.), Inc. · Anesthesiology device
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Aug 1981
Decision
17d
Days
Class 2
Risk

K812046 is an FDA 510(k) clearance for the TIDAL VOLUME MONITOR 150. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Medix Medical Electronics (U.S.A.), Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 Medix Medical Electronics (U.S.A.), Inc. devices

FDA 510(k) Submission Details - K812046

510(k) Number K812046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date August 07, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 39
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K812046.
SPIROMED RESPIROMETER
K831237 · Draeger Medical, Inc. · May 1983
COMPUTERIZED SPIROMETRY SYSTEM
K823922 · Ohio Medical Products · Feb 1983
BEAR VM-90 VENTILATION MONITOR
K822912 · Bear Medical Systems, Inc. · Nov 1982
RMS 111F RESPIRATORY MONITORING SYSTEM
K800086 · The Perkin-Elmer Corp. · May 1980
SPIROMETER, MINI POSITIVE
K782145 · Boehringer Laboratories · Jan 1979
SPIROMETER, MONITORING W/ALARM
K780064 · Ohio Medical Products · Jan 1978