Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5580](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5580) → BYG — Mask, Oxygen # BYG · Mask, Oxygen _Anesthesiology · 21 CFR 868.5580 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG ## Overview - **Product Code:** BYG - **Device Name:** Mask, Oxygen - **Regulation:** [21 CFR 868.5580](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5580) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. ## 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 (20 of 55) Showing 20 most recent of 55 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K963298](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K963298.md) | FIRST AID KIT(S) | Vector, Inc. | Nov 6, 1996 | SESE | | [K962848](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K962848.md) | HANS RUDOLPH NASAL CPAP MASK | Hans Rudolph, Inc. | Oct 16, 1996 | SESE | | [K945482](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K945482.md) | DISPOSABLE, CPAP OXYGEN MASK | Fvtnks | Sep 19, 1995 | SESE | | [K953464](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K953464.md) | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | Westmed, Inc. | Sep 18, 1995 | SESE | | [K953039](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K953039.md) | VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS | Dadsun Corp., Ltd. | Sep 15, 1995 | SESE | | [K945472](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K945472.md) | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | Westmed Intl. | Feb 7, 1995 | SESE | | [K942907](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K942907.md) | JEMSDAL MASK | Respan Products, Inc. | Aug 31, 1994 | SESE | | [K940888](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K940888.md) | SYSTEM 22 PAEDIATRIC MASK | Medic-Aid , Ltd. | Apr 19, 1994 | SESE | | [K940887](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K940887.md) | SYSTEM 22 ADULT MASK | Medic-Aid , Ltd. | Apr 19, 1994 | SESE | | [K931952](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K931952.md) | MEDWAY OXYGEN MASK | Medway | Aug 20, 1993 | SESE | | [K924069](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K924069.md) | SURGICO OXYGEN MASK | Gujarat Surgico, Ltd. | Feb 4, 1993 | SESE | | [K921499](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K921499.md) | SEAL RING FOR NASAL CPAP | Devilbiss Health Care, Inc. | Sep 17, 1992 | SESE | | [K913501](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K913501.md) | TRACHEOSTOMY MASK | B & F Medical Products, Inc. | Jan 13, 1992 | SESE | | [K913383](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K913383.md) | OXYGEN MASKS 81420, 81421, 81471 & 81461 | Specialty Packaging Producs, Inc. | Oct 18, 1991 | SESE | | [K913275](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K913275.md) | VENTURI OXYGEN MASK | Specialty Packaging Producs, Inc. | Oct 10, 1991 | SESE | | [K913455](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K913455.md) | OXYGEN MASKS 82400 & 82405 | Specialty Packaging Producs, Inc. | Oct 2, 1991 | SESE | | [K912633](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K912633.md) | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | Salter Labs | Jul 19, 1991 | SESE | | [K905288](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K905288.md) | ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES | Med-Tek Innovations, Inc. | Apr 9, 1991 | SESE | | [K904719](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K904719.md) | DISPOSABLE FACE MASK | Tri/Bor Medical, Inc. | Jan 2, 1991 | SESE | | [K904195](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K904195.md) | DISPOSABLE FACE MASK | Bp , Ltd. | Sep 25, 1990 | SESE | ## Top Applicants - Airlife, Inc. — 6 clearances - Ashai Co. , Ltd. — 4 clearances - B & F Medical Products, Inc. — 3 clearances - Dhd Medical Products Div. Diemolding Corp. — 3 clearances - Specialty Packaging Producs, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG) **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