đź“‹ FDA Reference
Reusable Ohmeda U410-02 Datex U410-09 Compatable Adult Finger Clip Sensor Phillips Adult Soft Tip Sensor U403S-91
Unimed Medical Supplies
Summary: The reusable Ohmeda U410-02 Datex U410-09 sensor is a medical device used for monitoring oxygen saturation in adult patients. It is commonly used by anesthesiologists and other clinicians in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082546 ↗
Decision Date ?
December 2, 2008
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510k pathway on December 2, 2008. It is manufactured by Unimed Medical Supplies and is classified as a Class 2 medical device.
What It Is
The reusable Ohmeda U410-02 Datex U410-09 sensor is a pulse oximetry device designed for adult patients. It works by attaching to the patient's finger and using light absorption to measure oxygen saturation levels in the blood. This device is compatible with specific monitoring systems, providing real-time data to clinicians.
FDA-Cleared Indications
- Noninvasive monitoring of arterial oxygen saturation in adult patients.
- Noninvasive monitoring of pulse rate in adult patients.
- Use with compatible pulse oximetry monitoring systems.
Clinical Applications
- Monitoring oxygen saturation during anesthesia and surgical procedures.
- Monitoring adults in intensive care and other hospital settings.
- Monitoring oxygenation during emergency evaluation and recovery.
- Monitoring adults with respiratory or cardiac conditions when pulse oximetry is clinically indicated.
Practical Considerations
- The sensor is intended for adult patients and should be positioned securely on a suitable finger according to the manufacturer’s instructions.
- Confirm connector and monitor compatibility before use; this model is identified as compatible with specified Ohmeda and Datex systems and Phillips adult soft-tip sensor references.
- Motion, poor circulation, cold extremities, nail products, improper placement, and external light can reduce signal quality or accuracy.
- This is a reusable device and should be cleaned, disinfected, inspected, and maintained according to the manufacturer’s instructions between patients.
- MRI safety is not established from the supplied FDA record; do not use it in an MRI environment unless the exact sensor and monitor system are specifically labeled MR Safe or MR Conditional.
Related Literature
The linked study compared three types of facemasks used during anesthesia induction, including a reusable rubber facemask by Datex Ohmeda. The study found differences in performance among the masks, highlighting the importance of choosing the right mask for patient comfort and effective ventilation. However, the study's focus was on facemasks, not directly on the sensor device.
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 the reusable Ohmeda U410-02 Datex U410-09 sensor used for?
It is used for monitoring oxygen saturation levels in adult patients.
What specialties typically use this device?
Anesthesiology, critical care, and emergency medicine specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for monitoring oxygen saturation in adult patients, particularly during anesthesia or in respiratory distress.
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.