Cleared Traditional

K812044 - RESPIRATION RATE MONITOR 120/121

K812044 is the FDA 510(k) clearance for RESPIRATION RATE MONITOR 120/121 by Medix Medical Electronics (U.S.A.), Inc.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812044 · Medix Medical Electronics (U.S.A.), Inc. · Anesthesiology device
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Aug 1981
Decision
14d
Days
Class 2
Risk

K812044 is an FDA 510(k) clearance for the RESPIRATION RATE MONITOR 120/121. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Medix Medical Electronics (U.S.A.), Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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

Submission Details

510(k) Number K812044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date August 04, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 39
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K812044.
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · Honeywell, Inc. · Oct 1981
NEO NATAL RESPIRATION FUNCTION BLOCK
K810175 · Honeywell, Inc. · Mar 1981
RESPIRATION FUNCTION BLOCKS
K810174 · Honeywell, Inc. · Mar 1981
PDS MODEL 3000 ADULT RESPIRATION MODULE
K802046 · General Electric Co. · Sep 1980