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hydrophilic coated catheter
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: The hydrophilic coated catheter is designed for intermittent catheterization, primarily used to improve patient comfort and reduce infection risk. Key evidence suggests improved quality of life and delayed onset of UTIs in spinal cord injury patients.
FDA Clearance Information
Pathway
510K
Number
K810023 ↗
Decision Date
February 6, 1981
Product Code
BSY
Device Class
Class 1
Evidence
419 studies
The hydrophilic coated catheter by Bd Becton Dickinson Vacutainer Systems Preanalytic was cleared via the FDA 510k pathway on February 6, 1981. It is classified as a Class 1 device under product code BSY.
What It Is
The hydrophilic coated catheter is a medical device used for intermittent catheterization. Its hydrophilic coating is intended to reduce friction and discomfort during insertion and removal, thereby minimizing urethral trauma and infection risk.
Clinical Applications
Commonly used in patients requiring intermittent catheterization, such as those with spinal cord injuries or other conditions leading to incomplete bladder emptying. It is particularly beneficial in reducing discomfort and urinary tract infections.
Evidence Summary
The literature includes 15 studies, ranging from observational to randomized controlled trials, conducted between 2011 and 2023. These studies evaluate quality of life, cost-effectiveness, and infection rates associated with hydrophilic coated catheters.
Reported Outcomes
Published studies report that hydrophilic coated catheters improve patient quality of life and delay the onset of urinary tract infections in patients with spinal cord injuries. They are also perceived positively by users for comfort and ease of use.
Safety Profile
Reported complications include urinary tract infections and urethral trauma, although the hydrophilic coating is designed to minimize these risks. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
While evidence supports the benefits of hydrophilic coated catheters, more research is needed to compare different catheter designs and their long-term cost-effectiveness. Some studies lack large sample sizes and long-term follow-up data.
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 are the clinical indications for hydrophilic coated catheters?
Hydrophilic coated catheters are indicated for intermittent catheterization in patients with incomplete bladder emptying, such as those with spinal cord injuries.
What outcomes have been reported in clinical studies?
Studies report improved quality of life, delayed onset of UTIs, and positive user perception regarding comfort and ease of use.
What complications have been reported?
Reported complications include urinary tract infections and urethral trauma, though the hydrophilic coating aims to reduce these risks.
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.