Monitor, Breathing Frequency
Anesthesiology · 21 CFR 868.2375
Recent MDR events
127 adverse event reports on file
- WEARABLE NASAL CANNUALJun 1, 2026DeathCurrent Health Ltd.MW5188818
- MONITOR, BREATHING FREQUENCYJan 8, 2026MalfunctionCovidien Llc2936999-2026-00008
- MASIMO SLEEPSep 16, 2022MalfunctionMasimo - 15750 Alton Pkwy3019388613-2022-00210
- PERSONAL SLEEP MONITORAug 23, 2022MalfunctionMasimo CorporationMW5111676
- MP5Apr 20, 2021MalfunctionPhilips Medical Systems9610816-2021-00068
- MP5Dec 29, 2020MalfunctionPhilips Medical Systems9610816-2020-00486
- MP5Oct 21, 2020MalfunctionPhilips Medical Systems9610816-2020-00385
- MP5Aug 28, 2020MalfunctionPhilips Medical Systems9610816-2020-00296
- MP5Jul 9, 2020MalfunctionPhilips Medical Systems9610816-2020-00225
- MP5Jun 18, 2020MalfunctionPhilips Medical Systems9610816-2020-00204
Event type breakdown
Recalls
3 recall events for this product code
- Salter Laboratories, Division of Regulatory AffairsTerminatedFeb 3, 2011
ThermiSense model 5700-A5
The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.
Z-1028-2011 · View FDA record ↗ - Respironics, Inc.TerminatedJul 27, 2004
Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
Z-1220-04 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedJul 20, 2004
Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
Device may not alarm for %SpO2 value limit violations if a specific feature is enabled
Z-1023-04 · View FDA record ↗
Registered firms
287 firms currently registered for this product code
Hypertec Hcm Llc
Plainfield, IN, US
Masimo Corporation
Irvine, CA, US
Masimo Corporation
Irvine, CA, US
Respiree Pte Ltd
Singapore Central Singapore, SG
Ryder Electronics (shenzhen) Ltd.
Shenzhen Guangdong, CN
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Industrial Vallera De Mexicali, S. A. De C. V.
Mexicali Mexico, MX
Conmed Corporation
WESTBOROUGH, MA, US
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Masimo Corporation
Irvine, CA, US
Jpex Medical Equipment & Supplies, Inc.
Ronkonkoma, NY, US
Salter Labs De Mexico De S.a. De C.v.
Chihuahua Mexico, MX
Faceheart Corp.
Taiwan Hsinchu (City), TW
Leonhard Lang Gmbh
INNSBRUCK Tirol, AT
Dongguan Smart Manufacturing Partner Electronic Company Limited
Dongguan, Guangdong, CN
Gereonics, Inc.
Irvine, CA, US
510(k) clearances
176 clearances for this product code
- Intelligent Dots, LLCJun 25, 2026
K253274 · BedDot (G1)
- Edwards Lifesciences, LLCJun 11, 2026
K251326 · Respiration Rate algorithm
- Linshom Medical, Inc.Sep 26, 2025
K250093 · Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- Respiree Pte, Ltd.Aug 5, 2025
K250934 · Respiree Cardio- Respiratory Monitor System
- Rtm Vital Signs, LLCJun 27, 2025
K243183 · RTMsense Respiratory Monitoring System
- Faceheart Corp.Apr 9, 2025
K243966 · FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
- Philips Medical Systems Nederland B.V.Apr 4, 2025
K242001 · Philips VSC-MEDlib
- Makani Science, Inc.Mar 28, 2025
K233953 · Makani Science Respiration Monitoring System