📋 FDA Reference
Philips Disposable SPO2 Sensors MII32A and M1133A
Philips Medizin Systeme Boeblingen
Summary: Philips Disposable SpO2 Sensors (MII32A and M1133A) are used for non-invasive monitoring of blood oxygen saturation levels. They are commonly used by clinicians in various healthcare settings, including hospitals and clinics.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K052377 ↗
Decision Date ?
November 17, 2005
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Disposable SpO2 Sensors were cleared through the FDA 510k pathway on November 17, 2005. Manufactured by Philips Medizin Systeme Boeblingen, these devices are classified as Class 2 under product code DQA.
What It Is
The Philips Disposable SpO2 Sensors are medical devices designed for the non-invasive measurement of blood oxygen saturation (SpO2) and pulse rate. These sensors work by emitting light through a patient's skin and measuring the amount of light absorbed by oxygenated and deoxygenated hemoglobin. They are typically used in conjunction with a compatible pulse oximeter monitor.
FDA-Cleared Indications
- Noninvasive monitoring of arterial oxygen saturation (SpO2).
- Noninvasive monitoring of pulse rate.
- Continuous or intermittent monitoring when oxygen saturation or pulse-rate measurement is clinically indicated.
Clinical Applications
- Monitoring oxygen saturation and pulse rate during anesthesia and surgery.
- Monitoring patients in intensive care and other hospital settings.
- Monitoring patients with respiratory conditions or suspected changes in oxygenation.
- Spot-checking or continuously monitoring oxygen saturation and pulse rate when clinically indicated.
Practical Considerations
- Use only with a pulse oximeter monitor specified as compatible by the manufacturer.
- Select the sensor size and placement appropriate for the patient and the labeled sensor configuration; versions may differ for adults and children.
- These are disposable, single-patient sensors and should not be reused between patients.
- Avoid placement over damaged skin and check the site regularly for pressure, irritation, poor perfusion, or inaccurate readings.
- MRI compatibility is not established by the information provided; follow the sensor and monitor labeling and the MRI facility's safety policy before use in an MRI environment.
Linked Studies (20)
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 • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Philips Disposable SpO2 Sensors used for?
They are used for non-invasive monitoring of blood oxygen saturation and pulse rate.
What specialties typically use this device?
Specialties such as anesthesiology, emergency medicine, and critical care commonly use these sensors.
What are the FDA-cleared indications?
The sensors are indicated for monitoring oxygen saturation and pulse rate in patients requiring continuous or spot-checking of these parameters.
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.