Well Lead All Silicone Foley Catheter with Temperature Sensor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K202134 ↗

FDA Product Code

EZL

FDA applicant

Well Lead Medical Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• All Silicone Foley Catheter

  Class IIb

  CE/MDR

• All Silicone Foley Catheter with Temperature Sensor

  Class IIb

  CE/MDR

• Urinary Drainage Catheter

  Class IIb

  CE/MDR

• Wellead Ureteral Stent Set

  Class IIa

  CE/MDR

• Latex Foley Catheter

  Class IIb

  CE/MDR

• Hydrophilic Latex Foley Catheter

  Class IIb

  CE/MDR

See all devices from Well Lead Medical Co., Ltd →

• What clinical settings is this catheter designed for and how does the temperature sensor benefit patients in those environments?

  This catheter is specifically designed for single-use urinary drainage in controlled clinical settings like operating rooms, intensive care units (ICU), and recovery areas. The integrated temperature sensor enables continuous bladder temperature monitoring, which can help clinicians assess patient hydration status, detect early signs of infection or fever, and provide real-time physiological data during critical procedures or prolonged monitoring.

• Is this catheter reusable or intended for single-use, and what does that mean for sterilization requirements?

  The catheter is explicitly designed for single-use only, meaning it is not meant to be reused after a single patient application. Since it is supplied sterile, no additional sterilization is required before use, simplifying workflow and reducing the risk of contamination. Discard it after use to comply with infection control protocols.

• What sizes are available for this catheter, and how do I determine the right size for a patient?

  This catheter is available in multiple sizes, referenced by FEI numbers (e.g., 3038139564, 1825146, etc.). The correct size depends on patient anatomy, typically measured in French (Fr) units, with common adult sizes ranging from 8Fr to 24Fr. Consult clinical guidelines or manufacturer sizing charts to match the patient’s urethral diameter or medical needs—commonly, smaller sizes (e.g., 12Fr–16Fr) are used for women or pediatric patients, while larger sizes (e.g., 18Fr–24Fr) may be needed for men or obese patients.

• How should this catheter be stored, and what precautions should be taken to maintain its sterility?

  The catheter is supplied sterile and should be stored in its original, unopened packaging to preserve sterility. Keep it in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid contamination by ensuring the sterile barrier remains intact until immediate use. Once opened, use it promptly and discard it immediately after use to prevent cross-contamination.

• What temperature range does the embedded sensor measure, and how might this feature assist clinicians?

  The integrated temperature sensor measures bladder temperature within a range of 25°C–45°C (77–113°F). This feature allows clinicians to monitor physiological changes in real-time, such as detecting fever, hypothermia, or bladder-related complications (e.g., infection or inflammation). It can be particularly useful in critical care settings where rapid assessment of patient stability is critical.