BZQ · Class II · 21 CFR 868.2375

FDA Product Code BZQ: Monitor, Breathing Frequency

Leading manufacturers include Linshom Medical, Inc., Hill-Rom, Inc. and Respiree Pte, Ltd..

174
Total
174
Cleared
155d
Avg days
1976
Since
Growing category - 8 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 236d recently vs 151d historically

FDA 510(k) Cleared Monitor, Breathing Frequency Devices (Product Code BZQ)

174 devices
1–24 of 174
Cleared Sep 26, 2025
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093
Linshom Medical, Inc.
Anesthesiology · 255d
Cleared Aug 05, 2025
Respiree Cardio- Respiratory Monitor System
K250934
Respiree Pte, Ltd.
Anesthesiology · 130d
Cleared Jun 27, 2025
RTMsense Respiratory Monitoring System
K243183
Rtm Vital Signs, LLC
Anesthesiology · 270d
Cleared Apr 09, 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K243966
Faceheart Corp.
Anesthesiology · 107d
Cleared Apr 04, 2025
Philips VSC-MEDlib
K242001
Philips Medical Systems Nederland B.V.
Anesthesiology · 269d
Cleared Mar 28, 2025
Makani Science™ Respiration Monitoring System
K233953
Makani Science, Inc.
Anesthesiology · 469d
Cleared Feb 28, 2025
Airmod
K242798
Heroic Faith International , Ltd.
Anesthesiology · 165d
Cleared Sep 11, 2024
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K240271
Linshom Medical, Inc.
Anesthesiology · 224d
Cleared Mar 08, 2023
Respiree Cardio-Respiratory Monitor
K223681
Respiree Pte, Ltd.
Anesthesiology · 90d
Cleared Dec 15, 2022
Dozee VS
K221555
Turtle Shell Technologies Private Limited
Anesthesiology · 198d
Cleared Nov 18, 2022
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K223246
Baxter Healthcare Corproration
Anesthesiology · 29d
Cleared Oct 07, 2022
RespiraSense
K220111
Pmd Solutions
Anesthesiology · 267d
Cleared Nov 23, 2021
Breathe Easy Mobile Respiratory Monitor (MRM)
K211387
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
K202018
Hill-Rom, Inc.
Anesthesiology · 226d
Cleared Jun 24, 2020
The C100 Contactless Breathing Monitor
K200445
Circadia Technologies, Ltd.
Anesthesiology · 121d
Cleared Jan 30, 2020
Linshom Respiratory Monitoring Device (LRMD)
K190734
Linshom Management, LLC
Anesthesiology · 315d
Cleared Dec 19, 2019
The RHEA Vital Sign Vigilance System
K190775
Shenzhen Fiber Medical Technology Co. , Ltd.
Anesthesiology · 268d
Cleared Sep 05, 2018
Masimo Acoustic Respiration Sensors, infant and neonate
K173976
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
K180079
Hill-Rom, Inc.
Anesthesiology · 117d
Cleared Jan 04, 2018
EarlySense Bed Sensing Unit
K171836
Earlysense, Ltd.
Anesthesiology · 198d
Cleared Aug 16, 1991
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415
Medtronic Vascular
Anesthesiology · 77d
Cleared Sep 16, 1980
PDS MODEL 3000 ADULT RESPIRATION MODULE
K802046
General Electric Co.
Anesthesiology · 22d

About Product Code BZQ - Regulatory Context

510(k) Submission Activity

174 total 510(k) submissions under product code BZQ since 1976, with 174 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 4 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 236 days to reach a decision - up from 151 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 →