📋 FDA Reference
Envisen Nellcor Bci Nonin Csi HP Philips Datex-Ohmeda Compatible Disposable and Reusable SPO2 Sensors
Shenzhen Envisen Industry
Summary: The Envisen SpO2 Sensors by Shenzhen Envisen Industry are used to monitor blood oxygen levels in patients. They are utilized by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K103584 ↗
Decision Date ?
June 10, 2011
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
419 studies
The Envisen SpO2 Sensors were cleared via the FDA 510(k) pathway on June 10, 2011. Manufactured by Shenzhen Envisen Industry, these devices are classified as Class 2 under product code DQA.
What It Is
The Envisen SpO2 Sensors are medical devices designed to measure the oxygen saturation levels in a patient's blood. They work by emitting light through a patient's tissue and measuring the light absorption to determine oxygen levels. These sensors are compatible with various monitoring systems, making them versatile in clinical settings.
FDA-Cleared Indications
- Monitoring arterial oxygen saturation and pulse rate in patients when pulse oximetry is indicated.
- Use with compatible pulse-oximetry monitoring equipment in clinical settings.
- Available in disposable and reusable configurations for appropriate patient monitoring applications.
Clinical Applications
- Continuous oxygen-saturation monitoring during anesthesia and surgery.
- Monitoring patients in critical-care, emergency, and hospital settings.
- Monitoring patients with respiratory or oxygenation concerns.
- Monitoring adult and pediatric patients when the sensor size and monitor compatibility are appropriate.
Practical Considerations
- Sensors are available in disposable and reusable formats; select the configuration, attachment method, and size appropriate for the patient and clinical setting.
- Confirm compatibility with the specific monitor before use. Listed compatible systems include Nellcor, BCI, Nonin, CSI, HP, Philips, and Datex-Ohmeda platforms, but connector and software compatibility should be verified.
- Place the sensor on a suitable site such as a finger, toe, or other labeled application site, and check that tissue perfusion and positioning are adequate for a reliable signal.
- Reusable sensors require cleaning and disinfection according to the manufacturer's instructions; disposable sensors should not be reused.
- Pulse-oximetry readings can be affected by motion, poor perfusion, ambient light, nail products, skin characteristics, and improper placement. The available FDA record does not establish these sensors as MRI-safe; verify MRI labeling 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 Envisen SpO2 Sensor used for?
The Envisen SpO2 Sensors are used to monitor blood oxygen saturation levels in patients.
What specialties typically use this device?
Specialties such as critical care, anesthesia, and emergency medicine commonly use these sensors.
What are the FDA-cleared indications?
The sensors are indicated for monitoring blood oxygen levels in patients, particularly in settings requiring continuous observation.
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.