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Tracheostomy Care Kit

by Superior Plastic Products Corp.

510(k) K761190

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK761190 Date16 Dec 1976ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1044-2024 FDA Class I initiated 4 Dec 2023

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

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  • Withdrawn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
BTO
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Tracheostomy Care Kit is a medical device designed for the maintenance and management of tracheostomy tubes, including those with or without connectors. It is intended to facilitate airway management in patients requiring prolonged mechanical ventilation or tracheal access, ensuring secure placement and proper ventilation to the lungs.

This kit is supplied as a single-use assembly and is intended for use in clinical settings such as intensive care units, operating rooms, and emergency departments. It is not classified as MRI-safe or MRI-conditional. The kit includes components compatible with various tracheostomy tube sizes and models, as referenced in the regulatory submissions. Its use is governed by FDA 510(k) clearance (K761190) under the Anesthesiology advisory committee classification, adhering to regulatory standards for Class II devices.

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Questions

AI-generated answers, 1 Oct 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 Tracheostomy Care Kit used for?

    The Tracheostomy Care Kit is designed to maintain and manage tracheostomy tubes, including those with or without connectors. It ensures proper airway management for patients requiring prolonged mechanical ventilation or tracheal access, helping to secure tube placement and facilitate ventilation to the lungs. This is particularly important in critical care settings like intensive care units, operating rooms, and emergency departments.

  • Is the Tracheostomy Care Kit single-use or reusable?

    The Tracheostomy Care Kit is supplied as a single-use assembly. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in clinical environments where hygiene and infection control are paramount.

  • What tracheostomy tube sizes and models is this kit compatible with?

    The kit is compatible with a wide range of tracheostomy tube sizes and models, as referenced in the regulatory submissions. This includes tubes with or without connectors, ensuring versatility for different clinical needs. The specific compatibility is supported by FDA clearance (K761190) under the Anesthesiology advisory committee classification.

  • How should the Tracheostomy Care Kit be stored?

    While the provided data does not specify storage conditions, single-use medical kits like this are typically stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Ensure the packaging remains intact until use to maintain sterility and functionality. Always follow manufacturer guidelines for optimal storage.

  • Is this kit MRI-safe or MRI-conditional?

    No, the Tracheostomy Care Kit is not classified as MRI-safe or MRI-conditional. This means it should not be used in MRI environments, as the materials or components may interfere with MRI imaging or pose risks during the procedure.