đź“‹ FDA Reference
urinary intermittent catheters w o hydromer hydrophilic lubricant
Biosearch Medical Products
Summary: Urinary intermittent catheters are medical devices used for bladder drainage in patients who cannot urinate naturally. They are primarily used by urologists and nurses in both hospital and home settings.
FDA Clearance Information
Pathway
510K
Number
K951260 ↗
Decision Date
September 27, 1995
Product Code
KOD
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510(k) pathway on September 27, 1995. Manufactured by Biosearch Medical Products, it is classified as a Class 2 device under product code KOD.
What It Is
Urinary intermittent catheters are thin, flexible tubes used to drain urine from the bladder. They are designed for temporary use and are inserted into the urethra to allow urine to pass directly out of the bladder. These catheters are essential for patients with urinary retention or neurogenic bladder conditions, providing a means to manage bladder emptying effectively.
Clinical Applications
Intermittent catheters are commonly used in urology, rehabilitation medicine, and home healthcare settings. They are particularly beneficial for patients with spinal cord injuries, multiple sclerosis, or post-surgical urinary retention. These catheters allow for periodic bladder drainage, reducing the risk of urinary tract infections and kidney damage.
Indications for Use
The FDA indicates these catheters for patients who need assistance with bladder drainage due to conditions like urinary retention or neurogenic bladder. They are suitable for both short-term and long-term management of these conditions.
Practical Considerations
Intermittent catheters come in various sizes to accommodate different patient needs, typically ranging from 6 to 16 French. They should be used with proper sterile technique to minimize infection risk. Compatibility with hydrophilic lubricants can enhance patient comfort during insertion.
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 urinary intermittent catheter used for?
It is used for draining urine from the bladder in patients who cannot urinate naturally.
What specialties typically use this device?
Urology, rehabilitation medicine, and home healthcare professionals commonly use these catheters.
What are the FDA-cleared indications?
These catheters are indicated for patients needing bladder drainage due to urinary retention or neurogenic bladder 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.