Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5100](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5100) → BTQ — Airway, Nasopharyngeal # BTQ · Airway, Nasopharyngeal _Anesthesiology · 21 CFR 868.5100 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ ## Overview - **Product Code:** BTQ - **Device Name:** Airway, Nasopharyngeal - **Regulation:** [21 CFR 868.5100](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5100) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K940320](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K940320.md) | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS | Ad-Tech Medical Instrument Corp | Sep 19, 1995 | SESE | | [K921353](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K921353.md) | NASOPHARYNGEAL AIRWAY | Coast Medical Corp. | Jun 11, 1992 | SESE | | [K911784](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K911784.md) | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | North American Sterilization & Packaging Co. | Sep 23, 1991 | SESE | | [K903618](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K903618.md) | ROBERTAZZI NASOPHARYNGEAL AIRWAY | Eastmed Enterprises, Inc. | Jan 8, 1991 | SESE | | [K900456](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K900456.md) | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Polamedco, Inc. | Apr 19, 1990 | SESE | | [K901279](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K901279.md) | CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY | Chatham Industries | Mar 28, 1990 | SESE | | [K883668](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K883668.md) | SUNDERLAND NASAL TUBE | Exmoor Plastics , Ltd. | Nov 21, 1988 | SESE | | [K873949](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K873949.md) | RORERTAZZI NASOPHARYNGEAL AIRWAY | Penn Medical Devices, Inc. | Oct 20, 1987 | SESE | | [K871673](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K871673.md) | NASOPHARYNGEAL AIRWAY | Harding Industries, Inc. | Jun 15, 1987 | SESE | | [K853162](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K853162.md) | STERILE NASOPHARYNGEAL AIRWAY | Inmed Corp. | Aug 6, 1985 | SESE | | [K850644](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K850644.md) | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Dryden Corp. | Mar 21, 1985 | SESE | | [K843524](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K843524.md) | LINDER NASOPHARYNGEAL AIRWAY | Polamedco, Inc. | Oct 4, 1984 | SESE | | [K841093](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K841093.md) | NASOPHARYNGEAL AIRWAYS | Inmed Corp. | Mar 23, 1984 | SESE | | [K834078](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K834078.md) | SILICONE RUGGER DISPOSABLE YOKE-CPAP | Vesta, Inc. | Dec 27, 1983 | SESE | | [K831476](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K831476.md) | NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE | Fls Medical Products, Inc. | Jun 10, 1983 | SESE | | [K830983](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K830983.md) | AIRWAYS & NASOPHARYNGEAL TYPE | Medovations, Inc. | May 9, 1983 | SESE | | [K810960](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K810960.md) | NASOPHARYNGEAL AIRWAY | Vesta, Inc. | Apr 23, 1981 | SESE | | [K792018](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K792018.md) | SILICONE RUBBER-BI NASOPHARYNGEAL AIR | Vesta, Inc. | Nov 13, 1979 | SESE | | [K760125](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ/K760125.md) | AIRWAY, ARGYLE NASOPHARYNGEAL | Sherwood Medical Industries | Jul 19, 1976 | SESE | ## Top Applicants - Vesta, Inc. — 3 clearances - Inmed Corp. — 2 clearances - Polamedco, Inc. — 2 clearances - Ad-Tech Medical Instrument Corp — 1 clearance - Chatham Industries — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTQ) **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:** Innolitics at https://innolitics.com