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Onyx II Finger Pulse Oximeter Model 9550
Nonin Medical
Summary: The Onyx II Finger Pulse Oximeter is a portable device used to measure peripheral oxygen saturation (SpO2) and pulse rate. It is commonly used by healthcare professionals in various settings, including hospitals and emergency services.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K051107 ↗
Decision Date ?
June 1, 2005
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
40 studies
The Onyx II Finger Pulse Oximeter by Nonin Medical was cleared through the FDA 510(k) pathway on June 1, 2005. It is classified as a Class 2 medical device under product code DQA.
What It Is
The Onyx II Finger Pulse Oximeter is a compact, non-invasive device designed to measure the oxygen saturation level in the blood and pulse rate. It works by using light-emitting diodes and a photodetector to calculate the ratio of oxygenated to deoxygenated hemoglobin. This device is particularly useful in monitoring patients with respiratory or cardiac conditions.
FDA-Cleared Indications
- Measurement of functional oxygen saturation of arterial hemoglobin (SpO2).
- Measurement of pulse rate.
- Use on patients weighing more than 30 kg.
Clinical Applications
- Spot-checking oxygen saturation and pulse rate in hospitals, clinics, and emergency medical services.
- Monitoring oxygenation during patient assessment and care.
- Use during procedures or anesthesia when noninvasive SpO2 and pulse-rate monitoring are indicated.
- Assessment of patients with suspected or known problems affecting oxygenation, when pulse oximetry is clinically appropriate.
Practical Considerations
- The device is intended for patients weighing more than 30 kg; it is not labeled for small infants or young children below this weight.
- Place the oximeter securely on the finger and keep the patient still for the most reliable reading. Motion, poor circulation, nail coverings, skin pigmentation, low signal strength, and ambient light can affect measurements.
- Pulse oximetry estimates oxygen saturation and does not directly measure blood oxygen or ventilation. Interpret results with the patient's symptoms and other clinical information.
- The device should not be used in an MRI scanner unless the manufacturer and facility specifically confirm MRI compatibility; conventional pulse oximeters may present a projectile, heating, or image-interference risk.
- Inspect the unit, clean it according to the manufacturer's instructions, and replace batteries as needed. Follow current labeling because specifications and service requirements may change.
Related Literature
The linked study compared the accuracy of handheld and finger-based pulse oximeters under various motion and environmental conditions. It found that different devices have varying levels of accuracy, influenced by their sensors and algorithms. The study highlights the importance of choosing the right device for specific conditions, though it is limited by its focus on a specific population and setting.
Linked Studies (20)
PubMed • 2026
Peripheral Vasculature Embolization with the Onyx Liquid Embolic System in a Swine Model.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent.
American heart journal
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
OnyxTMGel or Coil versus Hydrogel as Embolic Agents in Endovascular Applications: Review of the Literature and Case Series.
Gels (Basel, Switzerland)
View Source →PubMed • 2024
The resolute Onyx in TIA management (ROTIA).
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Spinal tumor embolization with Onyx: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Technical video: Onyx-18 embolization of spinal epidural arteriovenous Fistula using the scepter-Mini balloon catheter.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Delayed Migration of Onyx Embolic Agent after Preoperative Embolization of an Arteriovenous Malformation in a Pediatric Patient: A Case Report and Review of the Literature.
Pediatric neurosurgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
The Era of Onyx Embolization: A Systematic and Literature Review of Preoperative Embolization Before Stereotactic Radiosurgery for the Management of Cerebral Arteriovenous Malformations.
World neurosurgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Torcular dural AVF: Transvenous onyx embolisation with sinus reconstruction.
Clinical neurology and neurosurgery
View Source →PubMed • 2023
Retrieval of a Fractured Marathon Microcatheter Entrapped in Onyx Using a Novel Stentriever-Assisted Technique.
Operative neurosurgery (Hagerstown, Md.)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Onyx™ Cast Fragmentation After Embolization of Endoleaks.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Comparative Evaluation of Conventional and OnyxCeph™ Dental Software Measurements on Cephalometric Radiography.
Turkish journal of orthodontics
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
Dosimetric comparison of iPlanⓇ Pencil Beam (PB) and Monte Carlo (MC) algorithms in stereotactic radiosurgery/radiotherapy (SRS/SRT) plans of intracranial arteriovenous malformations.
Medical dosimetry : official journal of the American Association of Medical Dosimetrists
Retrospective View Source →PubMed • 2021
Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series.
Journal of neurointerventional surgery
Case Series View Source →PubMed • 2020
Percutaneous transorbital embolization of a carotid cavernous fistula.
Proceedings (Baylor University. Medical Center)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR).
Cardiology journal
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Onyx II Finger Pulse Oximeter used for?
It is used for measuring peripheral oxygen saturation (SpO2) and pulse rate in patients.
What specialties typically use this device?
Specialties such as pulmonology, cardiology, anesthesiology, and emergency medicine commonly use this device.
What are the FDA-cleared indications?
It is indicated for measuring blood oxygen levels and pulse rate, suitable for patients with respiratory or cardiac conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.