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Sign in to claim this brandTranstracheal Systems
US
Last updated May 23, 2026
What Transtracheal Systems makes
Transtracheal Systems manufactures transtracheal oxygen administration devices, including transtracheal catheters (such as the SCOOP and modified SCOOP variants) and related systems like the Transkinetics Rado Freq Multi-Lead Telemetry System 7200 and the Transtracheal Demand Oxygen Controller (DOC-2000).
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Transtracheal Systems manufacture?
Transtracheal Systems specializes in transtracheal oxygen administration devices. These include transtracheal catheters, such as the SCOOP and modified SCOOP variants, as well as systems like the Transkinetics Rado Freq Multi-Lead Telemetry System 7200 and the Transtracheal Demand Oxygen Controller (DOC-2000). These devices are designed to deliver oxygen directly into the trachea, offering an alternative to traditional nasal or mask-based oxygen therapy.
Where is Transtracheal Systems based?
Transtracheal Systems is based in the United States. The company’s location is relevant for regulatory and compliance purposes, as it operates under the jurisdiction of the FDA and adheres to U.S. medical device regulations.
Which regulatory registries list Transtracheal Systems’ devices?
Transtracheal Systems’ devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the 510(k) clearance process, ensuring they meet FDA requirements for safety and effectiveness before entering the market.
How are Transtracheal Systems’ devices classified under FDA regulations?
Transtracheal Systems’ devices fall under Class II classification according to FDA regulations. This classification indicates that they pose moderate risk and require special controls in addition to general controls to ensure their safety and performance. Examples include transtracheal catheters and related systems like the DOC-2000.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Scoop | C-13 | FDA UDI | Class II | Active |
| Scoop | C-13-2 | FDA UDI | Class II | Active |
| Scoop | C-13HF-2 | FDA UDI | Class II | Active |
| Scoop | C-9HF-2 | FDA UDI | Class II | Active |
| Scoop | C-11HF-2 | FDA UDI | Class II | Active |
| Scoop | C-11 | FDA UDI | Class II | Active |
| Scoop | C-9 | FDA UDI | Class II | Active |
| Scoop | C-9-2 | FDA UDI | Class II | Active |
| Scoop | C-11-2 | FDA UDI | Class II | Active |
| Transkinetics Rado Freq Multi-Lead Tele Syst 7200 | K904749 | FDA 510(k) | Class II | Active |
| Transtracheal Demand Oxygen Controller (doc-2000) | K962944 | FDA 510(k) | Class II | Active |
| Modified Scoop Transtracheal Catheters | K902281 | FDA 510(k) | Class II | Active |
| Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000 | K981078 | FDA 510(k) | Class II | Active |
| Transtracheal System-Scoop-Insertion Tray-Catheter | K854252 | FDA 510(k) | Class II | Active |
| Transkinetics Infrared Multi-Lead Tele Syst 7100 | K904748 | FDA 510(k) | Class II | Active |
| Transtracheal Demand Oxygen Controller Model Doc-3000 | K982943 | FDA 510(k) | Class II | Active |
| Scoop 1 | K981080 | FDA 510(k) | Class II | Active |
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