Oximeter
Cardiovascular · 21 CFR 870.2700
Recent MDR events
13,819 adverse event reports on file
- SpO2 CableJul 31, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101558
- Nasal Alar SpO2 SensorJul 29, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh1218950-2026-100526
- NellcoreJul 29, 2026MalfunctionNellcor Puritan Bennett Mexico Sa9610849-2026-00153
- EarlyVue VS30 Vitals monitorJul 28, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101519
- NellcorJul 28, 2026MalfunctionCovidien Llc2936999-2026-00291
- NellcorJul 28, 2026MalfunctionCovidien Llc2936999-2026-00292
- NellcorJul 28, 2026MalfunctionCovidien Llc2936999-2026-00293
- NellcorJul 28, 2026MalfunctionCovidien Llc2936999-2026-00294
- NellcorJul 28, 2026MalfunctionNellcor Puritan Bennett Mexico Sa1282497-2026-00043
- RD SET Neo Neonatal/Adult Pulse Ox SensorJul 28, 2026DeathMasimo - 15750 Alton Pkwy3019388613-2026-00475
Event type breakdown
Recalls
128 recall events for this product code
- SUREPULSE MEDICAL LTDOpen, ClassifiedFeb 12, 2026
Surepulse VS Cap Extra Small
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Z-1356-2026 · View FDA record ↗ - SUREPULSE MEDICAL LTDOpen, ClassifiedFeb 12, 2026
Surepulse VS Cap Small
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Z-1357-2026 · View FDA record ↗ - SUREPULSE MEDICAL LTDOpen, ClassifiedFeb 12, 2026
Surepulse VS Cap Medium
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Z-1358-2026 · View FDA record ↗ - SUREPULSE MEDICAL LTDOpen, ClassifiedFeb 12, 2026
Surepulse VS Cap Large
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Z-1359-2026 · View FDA record ↗ - SUREPULSE MEDICAL LTDOpen, ClassifiedFeb 12, 2026
Surepulse VS Cap Extra Large
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Z-1360-2026 · View FDA record ↗ - Edan DiagnosticsOpen, ClassifiedJan 22, 2026
Brand Name: EDAN
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1142-2026 · View FDA record ↗ - Edan DiagnosticsOpen, ClassifiedJan 22, 2026
Brand Name: EDAN
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1143-2026 · View FDA record ↗ - Edan DiagnosticsOpen, ClassifiedJan 22, 2026
Brand Name: EDAN
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1152-2026 · View FDA record ↗ - Edan DiagnosticsOpen, ClassifiedJan 22, 2026
Brand Name: EDAN
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1153-2026 · View FDA record ↗ - CovidienOpen, ClassifiedJul 21, 2025
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941,
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Z-2151-2025 · View FDA record ↗
Registered firms
1,369 firms currently registered for this product code
Industrial Vallera De Mexicali, S. A. De C. V.
Mexicali Mexico, MX
Shenzhen Witleaf Medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Gww
Gaertringen Baden-Wurttemberg, DE
Masimo Medical Technologies (malaysia) Sdn Bhd
Pasir Gudang Johor, MY
Masimo Corporation
Irvine, CA, US
Masimo Corporation
Irvine, CA, US
Empatica S.r.l.
Milano, IT
Philips North America Llc
ANDOVER, MA, US
Dik Fulfillment Services Inc
Lockport, IL, US
Nonin Medical, Inc.
Plymouth, MN, US
Philips North America Llc
Cambridge, MA, US
Simpro
Farmers Branch, TX, US
Breas Medical, Inc.
N Billerica, MA, US
Hamilton Medical Ag
Domat/Ems Graubunden, CH
Isomedix Operations Inc.
SAN DIEGO, CA, US
Carda Health
Houston, TX, US
Remware
Tampa, FL, US
Flash Global
Lockbourne, OH, US
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Shenzhen Mindray Bio-medical Electronics Co.,ltd
SHENZHEN Guangdong, CN
510(k) clearances
726 clearances for this product code
- Philips Medizin Systeme Böblingen GmbHMay 29, 2026
K252821 · Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- Shenzhen Imdk Medical Technology Co., Ltd.May 11, 2026
K252655 · Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- Philips Medizin SystemeMay 1, 2026
K253887 · Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- Unimed Medical Supplies, Inc.Apr 14, 2026
K260931 · Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- Avita CorporationFeb 27, 2026
K252448 · AViTA Pulse Oximeter (SP61)
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.Feb 17, 2026
K252805 · YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
- Shenzhen Best Electronics Co., Ltd.Jan 7, 2026
K253109 · Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
- Shenzhen Ykd Technology Co., Ltd.Dec 19, 2025
K251751 · Spo2 Sensor CSS032D