FDA Product Code BZQ: Monitor, Breathing Frequency
Leading manufacturers include Aequitron Medical, Inc., Healthdyne, Inc. and Edentec Corp..
176
Total
176
Cleared
157d
Avg days
1976
Since
Growing category -
9 submissions in the last 2 years
vs 5 in the prior period
Review times increasing: avg
260d
recently vs 152d historically
FDA 510(k) Cleared Monitor, Breathing Frequency Devices (Product Code BZQ)
176 devices
Cleared
Jun 25, 2026
BedDot (G1)
Intelligent Dots, LLC
Anesthesiology
269d
Cleared
Jun 11, 2026
Respiration Rate algorithm
Edwards Lifesciences, LLC
Anesthesiology
408d
Cleared
Sep 26, 2025
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Linshom Medical, Inc.
Anesthesiology
255d
Cleared
Aug 05, 2025
Respiree Cardio- Respiratory Monitor System
Respiree Pte, Ltd.
Anesthesiology
130d
Cleared
Jun 27, 2025
RTMsense Respiratory Monitoring System
Rtm Vital Signs, LLC
Anesthesiology
270d
Cleared
Apr 09, 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
Faceheart Corp.
Anesthesiology
107d
Cleared
Apr 04, 2025
Philips VSC-MEDlib
Philips Medical Systems Nederland B.V.
Anesthesiology
269d
Cleared
Mar 28, 2025
Makani Science™ Respiration Monitoring System
Makani Science, Inc.
Anesthesiology
469d
Cleared
Feb 28, 2025
Airmod
Heroic Faith International , Ltd.
Anesthesiology
165d
Cleared
Sep 11, 2024
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Linshom Medical, Inc.
Anesthesiology
224d
Cleared
Mar 08, 2023
Respiree Cardio-Respiratory Monitor
Respiree Pte, Ltd.
Anesthesiology
90d
Cleared
Dec 15, 2022
Dozee VS
Turtle Shell Technologies Private Limited
Anesthesiology
198d
Cleared
Nov 18, 2022
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
Baxter Healthcare Corproration
Anesthesiology
29d
Cleared
Oct 07, 2022
RespiraSense
Pmd Solutions
Anesthesiology
267d
Cleared
Nov 23, 2021
Breathe Easy Mobile Respiratory Monitor (MRM)
Sound Life Sciences, Inc.
Anesthesiology
202d
Cleared
Mar 04, 2021
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
Hill-Rom, Inc.
Anesthesiology
226d
Cleared
Jun 24, 2020
The C100 Contactless Breathing Monitor
Circadia Technologies, Ltd.
Anesthesiology
121d
Cleared
Jan 30, 2020
Linshom Respiratory Monitoring Device (LRMD)
Linshom Management, LLC
Anesthesiology
315d
Cleared
Dec 19, 2019
The RHEA Vital Sign Vigilance System
Shenzhen Fiber Medical Technology Co. , Ltd.
Anesthesiology
268d
Cleared
Sep 05, 2018
Masimo Acoustic Respiration Sensors, infant and neonate
Masimo Corporation
Anesthesiology
250d
Cleared
May 07, 2018
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
Hill-Rom, Inc.
Anesthesiology
117d
Cleared
Jan 04, 2018
EarlySense Bed Sensing Unit
Earlysense, Ltd.
Anesthesiology
198d
Cleared
May 06, 2016
EarlySense Insight Sytem
Earlysense, Ltd.
Anesthesiology
217d
Cleared
Mar 10, 2016
Thora-3Di, Model T-01
Pneumacare Limited
Anesthesiology
240d
About Product Code BZQ - Regulatory Context
510(k) Submission Activity
176 total 510(k) submissions under product code BZQ since 1976, with 176 receiving FDA clearance (average review time: 157 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - BZQ Product Code
Recent submissions under BZQ have taken an average of 260 days to reach a decision - up from 152 days historically. Manufacturers should account for longer review timelines in current project planning.
BZQ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →