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Temperature Sensor Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131020

by Degania Silicone Ltd

Identifiers

510(k) Number
K131020 FDA 510(k)
FDA Product Code
EZL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Retention Catheter, Balloon Type with an integrated temperature sensor, designed for urinary bladder drainage. It combines the functionality of a standard Foley catheter with real-time temperature monitoring capabilities, enabling precise physiological assessment during use. The sensor allows clinicians to measure bladder temperature, which may be relevant in specific diagnostic or therapeutic contexts.

The Temperature Sensor Catheter is supplied as a single-use, sterile medical device, intended for insertion into the urinary bladder via the urethra. Available in 6FR size, it is regulated under FDA 510(k) clearance (K131020) and classified as a Class II device under the regulation 21 CFR 876.5130. It is non-magnetic and compatible with MRI environments when used as directed. Storage and handling follow standard aseptic protocols for urinary catheters.

Frequently asked questions

What is the Temperature Sensor Catheter used for?

This device combines the functionality of a standard Foley catheter with an integrated temperature sensor, enabling clinicians to measure bladder temperature in real-time. This feature is particularly useful in specific diagnostic or therapeutic contexts where physiological assessment is critical, such as monitoring for infections, inflammation, or other conditions where bladder temperature may provide clinically relevant insights.

How is the Temperature Sensor Catheter supplied and what are its sterility and reuse details?

The Temperature Sensor Catheter is supplied as a single-use, sterile medical device. It is intended for one-time use only and must not be reused or reprocessed. Sterility is maintained through standard manufacturing protocols, ensuring it is safe for immediate clinical use upon opening. Always follow aseptic handling procedures to preserve sterility before insertion.

What size is available for the Temperature Sensor Catheter, and does it come in multiple models?

The Temperature Sensor Catheter is available in a single size: 6 French (6FR). As of the provided data, there is no indication of additional models or sizes being offered. If multiple sizes are required for clinical use, this device may need to be paired with other standard Foley catheters.

Can the Temperature Sensor Catheter be used in an MRI environment?

Yes, the Temperature Sensor Catheter is explicitly noted as non-magnetic and compatible with MRI environments when used as directed. This means it can be safely utilized in patients undergoing MRI scans, provided standard MRI safety protocols are followed alongside the device’s instructions for use.

What regulatory approvals does the Temperature Sensor Catheter hold, and how is it classified?

The Temperature Sensor Catheter holds FDA 510(k) clearance under the reference number K131020, with a decision dated May 9, 2013. It is classified as a Class II medical device under the regulation 21 CFR 876.5130, which governs retention catheters. This classification indicates it has undergone a higher level of scrutiny to ensure its safety and effectiveness for its intended use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QMD Degania Products | Silicone Catheters, Surgical Drains & Custom OEM ..., Temperature Sensor (Tsc) Silicone Catheters - TradeIndia, TEMPERATURE SENSOR CATHETER (K131020) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Degania Silicone Ltd
FDA Applicant
Degania Silicone , Ltd.

Sources (1)

  • FDA 510(k) K131020 24 fields · synced Oct 1, 2026