Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5620](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5620) → BYP — Mouthpiece, Breathing # BYP · Mouthpiece, Breathing _Anesthesiology · 21 CFR 868.5620 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP ## Overview - **Product Code:** BYP - **Device Name:** Mouthpiece, Breathing - **Regulation:** [21 CFR 868.5620](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5620) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices. ## 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 § 868.9. ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K955657](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K955657.md) | NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE | North State Plastics, Inc. | Mar 12, 1996 | SESE | | [K944512](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K944512.md) | TRUZONE PFM DISPOSABLE MOUTHPIECE | Monaghan Medical Corp. | Nov 2, 1994 | SESE | | [K893791](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K893791.md) | BREATHING MOUTHPIECE | Diemolding Corp. | Jun 23, 1989 | SESE | | [K872037](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K872037.md) | AEROCHAMBER | Monaghan Medical Corp. | Jul 24, 1987 | SESE | | [K865093](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K865093.md) | SAFE-T-SHIELD MOUTHPIECE | Medi Nuclear Corp., Inc. | Jan 15, 1987 | SESE | | [K863049](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K863049.md) | INHALATION AID | Boehringer Ingelheim Pharmaceuticals, Inc. | Oct 15, 1986 | SESE | | [K862788](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K862788.md) | MP-4400 MOUTHPIECE-FLANGE SEAL | Medipart Jerry Alexander | Aug 1, 1986 | SESE | | [K853575](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K853575.md) | MEDIPART MOUTHPIECE MP-1010 | Medipart Jerry Alexander | Oct 29, 1985 | SESE | | [K853574](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K853574.md) | MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 | Medipart Jerry Alexander | Oct 29, 1985 | SESE | | [K853572](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K853572.md) | MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 | Medipart Jerry Alexander | Oct 29, 1985 | SESE | | [K853266](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K853266.md) | PLASTIC MOUTH BARRIER HSV-I | Westmark Enterprises, Inc. | Oct 29, 1985 | SESE | | [K853402](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K853402.md) | E-Z-GUARD MOUTHPIECE | E-Z-Em, Inc. | Oct 23, 1985 | SESE | | [K840459](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K840459.md) | IMPROVED MOUTHPIECE | Kinetix | Feb 17, 1984 | SESE | | [K833420](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K833420.md) | KINETIX MOUTHPIECE | Kinetix | Jan 10, 1984 | SESE | | [K822437](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K822437.md) | MONAGHAN AEROCHAMBER | Monaghan Medical Corp. | Nov 3, 1982 | SESE | | [K821128](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K821128.md) | DISPOSABLE THERMOPLASTIC RUBBER MOUTH | Airlife, Inc. | May 13, 1982 | SESE | | [K810793](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K810793.md) | MOUTHPIECE, BREATHING | Dhd Medical Products Div. Diemolding Corp. | May 5, 1981 | SESE | | [K803069](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K803069.md) | SHELL KRATON THERMO-PLASTIC RUBBER COMP. | Warren E. Collins, Inc. | Dec 22, 1980 | SESE | | [K791537](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K791537.md) | DISPOSABLE MOUTHPIECE | Hospitak, Inc. | Sep 7, 1979 | SESE | | [K790933](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K790933.md) | MOUTHPIECE M-187 | Mem Medical, Inc. | May 21, 1979 | SESE | ## Top Applicants - Medipart Jerry Alexander — 4 clearances - Mem Medical, Inc. — 3 clearances - Monaghan Medical Corp. — 3 clearances - Airlife, Inc. — 2 clearances - Kinetix — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP) **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. 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