Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5600](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5600) → BYF — Mask, Oxygen, Low Concentration, Venturi # BYF · Mask, Oxygen, Low Concentration, Venturi _Anesthesiology · 21 CFR 868.5600 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF ## Overview - **Product Code:** BYF - **Device Name:** Mask, Oxygen, Low Concentration, Venturi - **Regulation:** [21 CFR 868.5600](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5600) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient. ## 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 | | --- | --- | --- | --- | --- | | [K955483](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K955483.md) | TRACH MASK MODEL (245, 246) | Hospitak, Inc. | Feb 28, 1996 | SESE | | [K951652](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K951652.md) | VENTIMASK MK IV | Flexicare Medical, Ltd. | Apr 27, 1995 | SESE | | [K894457](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K894457.md) | CARNATION TRACHEOSTOMY MASKS | Dadsun Corp., Ltd. | Oct 13, 1989 | SESE | | [K860873](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K860873.md) | VENTURI MASK/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | Mar 20, 1986 | SESE | | [K860874](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K860874.md) | VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | Mar 19, 1986 | SESE | | [K852618](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K852618.md) | OXY-DIAL | Ashai Co. , Ltd. | Sep 18, 1985 | SESE | | [K832725](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K832725.md) | DUAL DIAL VENTURI STYLE MASK | Airlife, Inc. | Sep 20, 1983 | SESE | | [K812066](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K812066.md) | PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN | Airlife, Inc. | Aug 3, 1981 | SESE | | [K810947](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K810947.md) | AIR ENTRAINMENT TRACH T | Airlife, Inc. | Jun 2, 1981 | SESE | | [K810946](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K810946.md) | ADULT & PEDIATRIC TRACHEOSTOMY MASKS | Airlife, Inc. | Jun 2, 1981 | SESE | | [K810373](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K810373.md) | VENTURI MASK/DELIVERY SYSTEM #'S | Todd Industries, Inc. | Mar 17, 1981 | SESE | | [K810430](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K810430.md) | VENTURI MASK/DELIVERY SYSTEM #6078 | Todd Industries, Inc. | Mar 13, 1981 | SESE | | [K790146](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K790146.md) | MASK, PERCENTO | Airlife, Inc. | Feb 6, 1979 | SESE | | [K781325](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K781325.md) | MARKII VENTIMASKS | Vickers America Medical Corp. | Sep 27, 1978 | SESE | | [K780626](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K780626.md) | VENTURI OXYGEN MASK | Hospitak, Inc. | May 26, 1978 | SESE | | [K780011](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K780011.md) | CONCHAPAK OXYGEN DILUTER | Respiratory Care, Inc. | Feb 2, 1978 | SESE | | [K772127](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K772127.md) | OXYGEN MASK, AIR-ENTRAINMENT | Salter Labs | Jan 3, 1978 | SESE | | [K771385](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K771385.md) | 2 JET SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 4, 1977 | SESE | | [K760518](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K760518.md) | ADAPTER, PER-CEN-TOX-BODY | Landmark Plastics | Sep 3, 1976 | SESE | ## Top Applicants - Airlife, Inc. — 5 clearances - Dhd Medical Products Div. Diemolding Corp. — 2 clearances - Hospitak, Inc. — 2 clearances - Todd Industries, Inc. — 2 clearances - Ashai Co. , Ltd. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF) **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