Pulse oximeters are noninvasive devices that measure oxygen saturation levels in the blood. They work by using light absorption through the skin to estimate how much oxygen is being carried by red blood cells.
In sleep medicine, pulse oximeters play a significant role in diagnosing and managing sleep disorders like obstructive sleep apnea. Sleep specialists use pulse oximeters to monitor these fluctuations throughout the night, identifying patterns that could indicate sleep apnea or other respiratory issues. By tracking blood oxygen saturation and heart rate, pulse oximeters help physicians understand the severity of a patient’s sleep disorder and tailor appropriate treatments.
Portable pulse oximeters are also commonly used in home sleep apnea testing. These devices allow patients to monitor their oxygen levels in the comfort of their own homes. This can facilitate efficacy checks on sleep apnea therapy, as well as longitudinal management.
After becoming indispensable during the height of the COVID-19 pandemic, pulse oximeters came under renewed scrutiny for health equity deficits as many pulse oximeters can give inaccurate readings for people with dark skin tones.
Pulse oximeters that are cleared by the US Food and Drug Administration (FDA) meet a minimum average accuracy, validated through desaturation studies on healthy patients for blood gas levels for saturations ranging from 70%-100%. The standard accuracy, denoted as Accuracy Root Mean Square (ARMS), for recently approved pulse oximeters falls within 2% to 3% of arterial blood gas values.
This guide to FDA-cleared pulse oximeters compares devices on parameters including form factor, SpO2 accuracy, pulse rate accuracy, battery life, and more.
The FDA-cleared pulse oximeters compared are:
Bodimetrics Circul+
Nonin Medical, Inc Nonin Model 7500 Pulse Oximeter
Nonin Medical, Inc Nonin WristOx2 Model 3150
OxiWear
Patient Safety, Inc SleepSat BLE
VirtuOx CardioSleep VPOD CapOx
VirtuOx CardioSleep VPOD ViTAL PRO
| Company Name: | BodiMetrics | Nonin Medical, Inc | Nonin Medical, Inc | OxiWear | Patient Safety, Inc | VirtuOx CardioSleep | VirtuOx CardioSleep |
|---|---|---|---|---|---|---|---|
| Pulse Ox: | Circul+ | Nonin Model 7500 Pulse Oximeter | Nonin WristOx2 Model 3150 | OxiWear | SleepSat BLE | VPOD CapOx | VPOD ViTAL PRO |
| Website: | circul.health | nonin.com/products/7500 | nonin.com/products/wristox2-model-3150-with-ble | oxiwear.com | patientsafetyinc.com | virtuox.net | virtuox.net |
| Description: | No pigmentation issue. Continuous blood oxygen and continuous heart rate at 1/100 hz. | The Nonin Model 7500 Pulse Oximeter empowers caregivers’ accurate oximetry measurements* in an easy to use, durable, and customizable device. It is a preferred choice for monitoring SpO2 in homecare settings, particularly for pediatric patients headed home for the first time. *Nonin Medical Inc data on file | The Nonin WristOx2 Model 3150 delivers accurate oxygen saturation and pulse rate readings including situations including low perfusion and motion.* It is compatible with a wide range of Nonin PureLight sensors and applications include overnight sleep tests, sleep apnea treatment monitoring, oxygen qualification, and pulmonary rehabilitation conducted at home and in the hospital. *Nonin Medical Inc data on file | Ear-wearable oximeter that provides real-time continuous data to an app as well as recording the data internally as a standalone device and provides haptic and text message alerts when oxygen levels are low. | High-resolution pulse oximeter for detection of all endotypes of sleep-disordered breathing. Short averaging time and 0.1% resolution provide better patterns of endotypes. Also included: motion, perfusion, and PPG. | Device records and stores SPO2, pulse, respiration, and ETCO2 and can be uploaded to VirtuOx IDFT for NIV patient qualifications. | Records and stores SPO2 and pulse, able to program alarms, and capable of uploading to VirtuOx IDTF. |
| FDA-Cleared Indications: | spot check and/or continuous data collection of oxygen saturation hemoglobin and pulse rate | simultaneously measuring, displaying, and recording functional (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is intended for spot-checking and/or continuous monitoring of patients during both motion and no-motion conditions, and for patients who are well or poorly perfused | measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking and/or data collection and recording of adult and pediatric patients, during both no motion and motion conditions, and for patients who are well or poorly perfused | noninvasive, spot checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients who are well or poorly perfused, during motion and non-motion conditions | [not provided] | spot check and continuous data collection | spot check and continuous data collection |
| Form Factor: | ring | handheld | wrist-worn | ear-worn | wrist-worn | handheld | handheld |
| SpO2 Accuracy within 70% – 100% range (Arms): | ±2.5 | ±2 | ±2 | ±3.5 | ±3 | ±2 | ±2 |
| Pulse Rate Accuracy within 30 – 240 bpm (Arms): | ±3 | ±3 | ±3 | ±3 | ±2 | ±2 | ±2 |
| Patient Range: | Adult | Neonate, Pediatric, Adult | Pediatric, Adult | Pediatric, Adult | Pediatric, Adult | Neonate, Pediatric, Adult | Neonate, Pediatric, Adult |
| Battery Life: (hours) | 14 | 16 | 53 (alkaline); 36 (rechargeable) | 12 | 20 | 10 | 24 |
| Health Equity Study: | Meira e Cruz, M, Zhou C, Kryger MH, Wang H. Validation of a smart ring oximeter in individuals with dark skin pigment. Mayo Clinic Pro: Dig Health. 2023. 1;3:357-65. | N/A | N/A | Performed as part of FDA-clearance testing. See page 3 of https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233827.pdf | Performed as part of FDA-clearance testing. | [not provided] | [not provided] |
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