Modified Foley Catheter/Temperature Sensor

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

510(k) Number

K874525 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Mon-A-Therm's Skin Temperature Sensor

  Class II

  FDA 510(k) K875234 Active Cleared 19 Jan 1988

• Modified Airway Temperature Sensor

  Class II

  FDA 510(k) K874520 Active Cleared 6 Jan 1988

• Modified Esophageal Stethoscope/Temperature Sensor

  Class I

  FDA 510(k) K874519 Active Cleared 29 Jan 1988

• Temperature Trend Indicator (TTI)

  Class II

  FDA 510(k) K820426 Active Cleared 8 Mar 1982

• Modified Tympanic & Esophageal/Rectal Temp. Sensor

  Class II

  FDA 510(k) K874523 Active Cleared 6 Jan 1988

• Airway Temperature Sensor

  Class II

  FDA 510(k) K821505 Active Cleared 9 Dec 1982

See all devices from Mon-A-Therm, Inc. →

• What clinical settings is this device intended for and how does the temperature sensor feature benefit patients?

  This Modified Foley Catheter with Temperature Sensor is designed for single-use in clinical settings like hospitals and urology practices. The integrated temperature sensor allows clinicians to monitor bladder temperature during use, which can help assess patient physiology—such as hydration status, fever, or other systemic conditions—without requiring additional invasive procedures.

• Is this device reusable or single-use, and how should it be stored to maintain sterility?

  The device is explicitly intended for single-use only, as stated in the manufacturer’s specifications. It is supplied sterile, so storage should follow sterile packaging guidelines: keep in a clean, dry environment away from direct sunlight or extreme temperatures until use. Avoid contamination by ensuring the packaging remains intact until deployment.

• What regulatory pathway was followed for FDA clearance, and does this device have any MRI compatibility?

  The device received FDA 510(k) clearance under the Substantially Equivalent determination (K874525), filed in 1987 and classified under urological catheters (product code KOD). Importantly, the device is not MRI-compatible, so it should not be used in MRI environments. The clearance does not imply broader regulatory status beyond this specific submission.

• Are there multiple sizes or models available for this catheter, and how would I determine the correct fit for a patient?

  The provided data lists multiple FEI numbers (e.g., 1825146, 3030447506) and registration numbers, which typically correspond to different sizes or variations of the device. While exact sizing details (e.g., French sizes) aren’t specified here, these identifiers suggest availability in standard urological catheter sizes. Clinicians should refer to the manufacturer’s packaging or catalog for size-specific guidance to ensure proper patient fit.