Product code BZQ— Anesthesiology
INFANT MONITOR
- Classification name
- Monitor, Breathing Frequency
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Total cleared
- 176
- First cleared
- Most recent
Market context for product code BZQ
FDA has cleared devices under product code BZQ between 1976 and 2026, filed by 110 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2016
- 2014
- 2013
- 2012
- 2011
- 2010
Top applicants under product code BZQ
Recent clearances under product code BZQ
1–100 of 176- K253274 — BedDot (G1)
- K251326 — Respiration Rate algorithm
- K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- K250934 — Respiree Cardio- Respiratory Monitor System
- K243183 — RTMsense Respiratory Monitoring System
- K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
- K242001 — Philips VSC-MEDlib
- K233953 — Makani Science Respiration Monitoring System
- K242798 — Airmod
- K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- K223681 — Respiree Cardio-Respiratory Monitor
- K221555 — Dozee VS
- K223246 — Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
- K220111 — RespiraSense
- K211387 — Breathe Easy Mobile Respiratory Monitor (MRM)
- K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
- K200445 — The C100 Contactless Breathing Monitor
- K190734 — Linshom Respiratory Monitoring Device (LRMD)
- K190775 — The RHEA Vital Sign Vigilance System
- K173976 — Masimo Acoustic Respiration Sensors, infant and neonate
- K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
- K171836 — EarlySense Bed Sensing Unit
- K152911 — EarlySense Insight Sytem
- K151940 — Thora-3Di, Model T-01
- K133661 — CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
- K132320 — INTELLIVUE CL RESPIRATION POD
- K130570 — NEUROVISION MEDICAL MOTION SENSOR
- K131379 — EARLYSENSE
- K122223 — NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
- K120465 — EARLYSENSE (EVERON) SYSTEM
- K111933 — COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
- K103631 — SLEEPMINDER BREATHING FREQUENCY INDICATOR
- K100773 — KAI SPOT MODEL KMS 200
- K092062 — EVERON 1.0
- K092685 — PNEUMOTHERML, MODEL: 5800
- K090273 — KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
- K082465 — EVERON
- K080922 — SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
- K070375 — EARLYSENSE ES-16 SYSTEM
- K062883 — GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
- K051779 — ANDROFLOW - RESPIRATORY RATE MONITOR
- K040605 — DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
- K003704 — OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
- K001743 — ULTIMA SMARTBELT, MODEL 0560
- K001030 — RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
- K991411 — GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
- K983449 — GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
- K981725 — OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
- K984431 — ULTIMA AIRFLOW PRESSURE SENSOR
- K981445 — ULTIMA AIRFLOW SENSOR, 0510
- K982550 — BROWSER (EVENT SOFTWARE) MODEL # 4500E
- K982216 — ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
- K981728 — ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
- K961972 — MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
- K962781 — COROMETRICS MODEL 510 AND 511 MONITOR
- K960851 — THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
- K953363 — OXIFLOW DIGITAL RECORDER
- K943308 — MODEL 510 INFANT MONITOR
- K942170 — MODEL 511 INFANT MONITOR
- K940014 — PLM SENSOR, MODEL PLM1
- K941759 — SNORING SENSOR
- K924875 — MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
- K935518 — MOVING IMAGES(TM)
- K932902 — MAGNUM
- K930790 — ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
- K923737 — MODEL MEDILOG RAPIDE
- K921819 — EDENTEC MODEL 3710 I DIGITAL PRINTER
- K925364 — MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
- K923402 — CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
- K922112 — EASYFLOW
- K913749 — EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
- K911874 — SLEEPTRACE 2000
- K911386 — SLEEPMASTER
- K912415 — MEDICAL SAFETY CABLE AND LEAD SYSTEM
- K904432 — SLEEP I/T-5 AND SLEEP I/T-8
- K905575 — MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
- K905520 — MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
- K903020 — RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
- K903011 — RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
- K904396 — SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM
- K903300 — RESP-EZ(TM) RESPIRATORY MONITORING BELT
- K903287 — MODEL 900S APNEA/HEART MONITOR
- K900264 — R-BAND(TM) RESPIRATORY SENSOR
- K884120 — TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
- K901656 — MODEL 9200 RESPIRATION/HEART RATE MONITOR
- K902785 — MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
- K896934 — KNIGHTWATCH SYSTEM
- K900730 — ARVEE APNEA MONITOR, MODEL 4800
- K901466 — MESAMIV RECORDER
- K900826 — 'APNEA-ELECTRODE'
- K894641 — MESAM RECORDER
- K891486 — AR-800PA RESPIRATION MODULE
- K891676 — ARVEE APNEA MONITOR, MODEL 2400
- K883158 — RESPIRATORY AIRWAY TUBE MONITOR (RATM)
- K884637 — MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
- K882377 — HEALTH-WATCH BED MONITOR
- K880725 — SAM(TM) MODEL ONE
- K862747 — 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS
- K881266 — MODEL 9216 RESPIRATION/HEART RATE MONITOR
- K872833 — BREATHGUARD APNEA MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.