Skip to content

Tetley Patient Administration Set

by Tetley Medical, Ltd.

510(k) K913416

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913416 Date28 Oct 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYT
FDA applicant
Tetley Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1390
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tetley Patient Administration Set is a System, Rebreathing, Radionuclide designed for use in radiology procedures. It facilitates the controlled delivery and rebreathing of radiopharmaceuticals during diagnostic imaging, ensuring precise administration to patients while maintaining system integrity.

This device is intended for single-use in radiology settings and complies with FDA 510(k) clearance (K913416) under regulation 892.1390. Supplied sterile and packaged for one-time use, it requires no reprocessing. The system is classified as Class II and adheres to radiology-specific standards for safe handling of radionuclides. Storage follows manufacturer guidelines to preserve sterility and functionality.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Tetley Patient Administration Set in a clinical setting?

    The Tetley Patient Administration Set is specifically designed for use in radiology procedures to facilitate the controlled delivery and rebreathing of radiopharmaceuticals during diagnostic imaging. It ensures precise administration while maintaining system integrity to safely handle radionuclides.

  • Is the Tetley Patient Administration Set intended for single-use or repeated use, and why?

    The Tetley Patient Administration Set is intended for single-use only. This is explicitly stated in the device description, which emphasizes it is supplied sterile and packaged for one-time use, requiring no reprocessing to maintain safety and sterility standards.

  • How should the Tetley Patient Administration Set be stored to maintain its integrity?

    Storage instructions follow manufacturer guidelines to preserve sterility and functionality. While the exact conditions aren’t detailed, the device’s single-use, sterile packaging implies it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.

  • What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

    The Tetley Patient Administration Set received FDA clearance through a Traditional 510(k) pathway (K913416) under regulation 892.1390, with a decision of Substantially Equivalent (SESE). It is classified as a Class II device, adhering to radiology-specific standards for radionuclide handling.

  • Are there multiple models or sizes available for the Tetley Patient Administration Set, and how can I identify them?

    The provided data lists multiple registration numbers (e.g., 3009140376, 2518443) and FEI numbers, which may correspond to different models or variations of the device. However, the exact specifications (e.g., tubing lengths, connector types) aren’t detailed in the summary. Contacting Tetley Medical, Ltd. directly would clarify available models or sizes.