Cleared Traditional

K903020 - RESPIRATION/HEART RATE MONITOR MODEL 9500/9550

K903020 is an FDA 510(k) clearance for RESPIRATION/HEART RATE MONITOR MODEL 95..., manufactured by Aequitron Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K903020 · Aequitron Medical, Inc. · Anesthesiology device
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Apr 1991
Decision
273d
Days
Class 2
Risk

K903020 is an FDA 510(k) clearance for the RESPIRATION/HEART RATE MONITOR MODEL 9500/9550. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 10, 1991 after a review of 273 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aequitron Medical, Inc. devices

FDA 510(k) Submission Details - K903020

510(k) Number K903020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date April 10, 1991
Days to Decision 273 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
133d slower than avg
Panel avg: 140d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K903020.
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415 · Medtronic Vascular · Aug 1991
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · Edentec Corp. · Jun 1991
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K905520 · Synectics-Dantec · Apr 1991
MODEL 900S APNEA/HEART MONITOR
K903287 · Healthdyne, Inc. · Aug 1990
R-BAND(TM) RESPIRATORY SENSOR
K900264 · Buckman Co., Inc. · Jul 1990
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120 · S & W Medico Teknik · Jul 1990