← Product Code [BTO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO) · K801931 # MARTIN TRACH-SECURE (K801931) _Acucare Medical, Inc. · BTO · Aug 27, 1980 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K801931 ## Device Facts - **Applicant:** Acucare Medical, Inc. - **Product Code:** [BTO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO.md) - **Decision Date:** Aug 27, 1980 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5800 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K801931](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K801931) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K801931