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Tracheostomy Care Tray

by Paco Research Corp.

510(k) K850445

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK850445 Date11 Mar 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
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 Tray is a Class II medical device designed for the maintenance and care of tracheostomy patients. It is intended to provide organized access to essential supplies and instruments required for cleaning, suctioning, and managing tracheostomy tubes, ensuring proper hygiene and patient comfort during post-operative or prolonged tracheostomy care.

This device is supplied as a reusable tray and is intended for use in clinical settings such as operating rooms, intensive care units, and recovery areas. It is not sterile and must be cleaned and disinfected between uses. The tray is regulated under FDA 510(k) clearance (K850445) and falls under the product code BTO, with an advisory committee classification in Anesthesiology. No specific MRI safety information or single-use designation is provided.

Other devices from Paco Research Corp.

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 Paco Tracheostomy Care Tray used for?

    The Paco Tracheostomy Care Tray is designed to provide organized access to essential supplies and instruments required for cleaning, suctioning, and managing tracheostomy tubes. It ensures proper hygiene and patient comfort during post-operative or prolonged tracheostomy care in clinical settings like operating rooms, intensive care units, and recovery areas.

  • Is the Paco Tracheostomy Care Tray sterile?

    No, the Paco Tracheostomy Care Tray is not sterile. It is intended for reusable use in clinical settings and must be cleaned and disinfected between each use to maintain proper hygiene standards.

  • How is the Paco Tracheostomy Care Tray supplied?

    The tray is supplied as a reusable clinical tool, intended for use in organized healthcare environments. It is not packaged as a single-use item and requires proper cleaning and disinfection procedures between uses to ensure safety and functionality.

  • What regulatory pathway does the Paco Tracheostomy Care Tray follow?

    The Paco Tracheostomy Care Tray is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K850445. It falls under product code BTO and is classified under the Anesthesiology advisory committee, indicating its use in procedural and critical care settings.

  • Can the Paco Tracheostomy Care Tray be used with different tracheostomy tube types?

    The tray is designed to support the maintenance and care of tracheostomy tubes, including those with or without connectors, as indicated by its FDA clearance and associated registration numbers. However, compatibility with specific tube models should be verified by the clinician to ensure proper fit and functionality of included instruments.