YSI Models 4400 Foley Catheter Temperature Probes
by Ysis, Inc.
510(k) K921561
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921561 | Date23 Nov 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The YSI Models 4400 Foley Catheter Temperature Probes are a type of retention balloon catheter designed for measuring temperature within the urinary bladder. These probes integrate a temperature sensor to provide real-time thermal data during clinical procedures, aiding in monitoring and diagnostic assessments in urological and gastroenterological settings.
These probes are supplied as sterile, single-use devices and are intended for use in medical environments where precise temperature measurement is required. Available in multiple French sizes (14, 16, and 18FR), they are compatible with Foley catheters and are regulated under FDA 510(k) clearance (K921561). Storage and handling follow standard sterile medical device protocols to ensure reliability and safety.
Other devices from Ysis, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical specialties commonly use the YSI Models 4400 Foley Catheter Temperature Probes, and why are they relevant in those fields?
The YSI Models 4400 Foley Catheter Temperature Probes are primarily used in urology and gastroenterology settings. These specialties rely on precise temperature monitoring during procedures involving the urinary bladder, such as bladder irrigation or diagnostic assessments, where real-time thermal data can help assess patient stability, detect complications (e.g., infections or obstructions), or guide therapeutic interventions like hyperthermia treatments.
Are the YSI Models 4400 Foley Catheter Temperature Probes reusable, or are they designed for single-use only?
These probes are sterile, single-use devices, as explicitly stated in the manufacturer’s specifications. Single-use design ensures patient safety by eliminating cross-contamination risks and maintains accuracy, as reuse could compromise sensor integrity or introduce microbial contamination.
What sizes are available for the YSI Models 4400 Foley Catheter Temperature Probes, and how do I determine the appropriate size for a patient?
The probes come in three French sizes: 14FR, 16FR, and 18FR, which correspond to varying catheter diameters. Selection depends on patient anatomy (e.g., urethral size) and clinical procedure requirements—consult manufacturer guidelines or a urologist to match the probe size to the Foley catheter being used, ensuring proper fit and functionality without causing trauma.
How should the YSI Models 4400 Foley Catheter Temperature Probes be stored to maintain sterility and functionality?
Storage follows standard sterile medical device protocols, meaning they should be kept in their original, sealed packaging until use. The packaging should be protected from moisture, extreme temperatures, and physical damage to preserve sterility and sensor accuracy. Always check expiration dates and avoid exposing the probe to contaminants before insertion.
What regulatory pathway was followed for FDA clearance of the YSI Models 4400 Foley Catheter Temperature Probes, and what does that mean for clinicians?
The device received FDA 510(k) clearance (K921561) under a *Traditional* review pathway, determined to be *Substantially Equivalent* to a predicate device. This means the FDA evaluated it against existing, legally marketed catheters with temperature-sensing capabilities and confirmed it meets safety and performance standards. Clinicians can trust its compliance with U.S. regulatory requirements for temperature measurement in Foley catheters.