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TubeClear Model 101 (With New Clearing Stem NE and G Models)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131052

by Actuated Medical, Inc.

Identifiers

510(k) Number
K131052 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TubeClear Model 101 is a Clogged Feeding Tube Clearing System (Product Code: KNT), designed to clear obstructions in existing feeding or decompression tubes. It consists of a reusable Control Box paired with single-use Clearing Stems (NE and G models) that are manually inserted into the tube to restore patency.

This device is intended for bedside use in clinical settings such as gastroenterology and urology. The reusable Control Box (Model 101) is paired with sterile, single-use Clearing Stems, and the system has received FDA 510(k) clearance under the Traditional pathway. No MRI safety or size-specific storage instructions are provided in the submitted data.

Frequently asked questions

What clinical specialties would most commonly use the TubeClear Model 101 system in their practice?

The TubeClear Model 101 is primarily designed for bedside use in gastroenterology and urology departments, where clogged feeding or decompression tubes are most frequently encountered. Its manual insertion and clearing mechanism make it suitable for restoring patency in existing tubes without requiring specialized equipment beyond the reusable Control Box and single-use Clearing Stems.

How is the TubeClear system supplied, and what does the single-use component entail?

The TubeClear Model 101 system consists of a reusable Control Box paired with sterile, single-use Clearing Stems (available in NE and G models). The Clearing Stems are manually inserted into the clogged tube to clear obstructions, while the Control Box remains reusable for multiple procedures. This design ensures sterility per use while minimizing waste from disposable components.

Are there specific tube sizes or types this device is compatible with, or does it require customization?

The TubeClear Model 101 is designed to clear obstructions in existing feeding or decompression tubes, but the exact compatibility depends on the tube’s internal diameter and the Clearing Stem model (NE or G) selected. The system is not size-specific in its packaging, so clinicians must ensure the chosen Clearing Stem matches the tube’s dimensions for effective clearing. No additional customization is required beyond selecting the appropriate stem.

How should the single-use Clearing Stems be stored before use, and are there any special handling instructions?

The single-use Clearing Stems are sterile and should be stored according to standard medical device packaging guidelines—typically in a clean, dry environment protected from contamination. Since no MRI safety or size-specific storage instructions are provided, they can be kept at room temperature until use, following the manufacturer’s general storage recommendations for single-use medical devices. Avoid exposure to extreme temperatures or moisture.

What distinguishes the NE and G models of Clearing Stems, and how would a clinician choose between them?

The NE and G models of Clearing Stems are differentiated by their design specifications tailored for different tube types or obstruction scenarios, though the exact distinctions (e.g., diameter, shape, or clearing mechanism) are not detailed in the provided data. Clinicians would select the appropriate model based on the tube’s internal diameter and the type of obstruction (e.g., solid vs. liquid blockage) they aim to clear. The manufacturer’s instructions or compatibility charts would guide this choice.

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: Tubeclear Model 101 (With New Clearing Stem Ne and G Models), Tubeclear Model 101 (With New Clearing Stem Ne and G Models), TubeClear - Clogged Feeding Tube Clearing System, Support - tubeclear.com, PDF K131052 Tubeclear Model 101 (With New Clearing Stem Ne and G Models)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Actuated Medical, Inc.

Sources (1)

  • FDA 510(k) K131052 24 fields · synced Sep 19, 2026