📋 FDA Reference
Thinkmed Intermittent Catheter with Without Hydrophilic Coating
Thinkmed Medical Technology
Summary: The Thinkmed intermittent catheter is a medical device used for bladder drainage in patients who cannot urinate naturally. It is typically used by urologists and other healthcare professionals in both hospital and home settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142767 ↗
Decision Date ?
February 3, 2015
Product Code ?
GBM
Device Class ?
Class 2
Evidence ?
419 studies
The Thinkmed intermittent catheter was cleared through the FDA 510(k) pathway on February 3, 2015. Manufactured by Thinkmed Medical Technology, it is classified as a Class 2 device under product code GBM.
What It Is
The Thinkmed intermittent catheter is a tube-like device designed for temporary bladder drainage. It may come with or without a hydrophilic coating, which facilitates smoother insertion and reduces friction. This device is typically used in patients with urinary retention or neurogenic bladder conditions, providing an effective means of bladder management.
FDA-Cleared Indications
- Intermittent catheterization for bladder drainage in patients who cannot adequately empty their bladder.
- Use through the urethra to drain urine from the bladder.
- Available in versions with or without a hydrophilic coating to facilitate catheter insertion.
Clinical Applications
- Intermittent bladder drainage for urinary retention.
- Bladder emptying in patients with neurogenic bladder or impaired bladder function.
- Urethral catheterization in hospital, clinic, or home-care settings when performed by a trained patient, caregiver, or healthcare professional.
Practical Considerations
- The catheter is available in different sizes; the appropriate French size and length depend on patient anatomy, age, sex, and clinical requirements.
- Hydrophilic-coated versions generally require activation with sterile water or water according to the product instructions before insertion.
- Use clean or sterile technique as directed by the treating clinician, with hand hygiene and appropriate lubrication or catheter preparation.
- Do not use if the catheter package is damaged, contaminated, or past its labeled expiration date.
- The FDA record does not establish MRI safety; check the current product labeling or contact the manufacturer before MRI use. Contraindications and precautions should be reviewed in the device instructions and by the treating clinician.
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 Thinkmed intermittent catheter used for?
It is used for bladder drainage in patients who cannot urinate naturally due to conditions like urinary retention or neurogenic bladder.
What specialties typically use this device?
Urologists, nurses, and other healthcare professionals involved in bladder management and care for patients with urinary retention or neurogenic bladder.
What are the FDA-cleared indications?
The device is indicated for patients requiring intermittent catheterization for 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.