Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5550](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5550) → BSJ — Mask, Gas, Anesthetic # BSJ · Mask, Gas, Anesthetic _Anesthesiology · 21 CFR 868.5550 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ ## Overview - **Product Code:** BSJ - **Device Name:** Mask, Gas, Anesthetic - **Regulation:** [21 CFR 868.5550](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5550) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper 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 (20 of 51) Showing 20 most recent of 51 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K163277](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K163277.md) | SuperNO2VA Device | Revolutionary Medical Devices, Inc. | Oct 13, 2017 | SESE | | [K953107](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K953107.md) | ANESTHESIA/RESPIRATORY FACE MASK | Medical Marketing Concepts | Aug 15, 1995 | SESE | | [K953295](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K953295.md) | ANESTHESIA FACE MASK | Mallinckrodt Medical | Aug 11, 1995 | SESE | | [K952689](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K952689.md) | BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK | Owens-Brigam Medical Co. | Jul 11, 1995 | SESE | | [K951043](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K951043.md) | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK | Promedic, Inc. | Jun 7, 1995 | SESE | | [K950771](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K950771.md) | DISPOSABLE ADHESIVE FACE MASK | Advanced Warming Systems, Inc. | Mar 10, 1995 | SESE | | [K945894](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K945894.md) | MASK, GAS, ANESTHETIC | Hans Rudolph, Inc. | Jan 27, 1995 | SESE | | [K945440](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K945440.md) | DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK | Fvtnks | Nov 8, 1994 | SESE | | [K944157](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K944157.md) | DISPOSABLE, PREFORMED FACE MASK | Meridian Medical Systems, Inc. | Oct 3, 1994 | SESE | | [K932147](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K932147.md) | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE | Hans Rudolph, Inc. | Aug 20, 1993 | SESE | | [K932014](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K932014.md) | AMBU DISPOSABLE FACE MASK | Ambu, Inc. | Jun 22, 1993 | SESE | | [K915558](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K915558.md) | IAS ANESTHESIA MASK | Ias | Apr 8, 1992 | SESE | | [K903881](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K903881.md) | VENTLAB VENT-MASK, CAT# VR 0010/20/30 | Ventlab Corp. | Sep 4, 1990 | SESE | | [K902298](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K902298.md) | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS | Rondex Products, Inc. | Aug 22, 1990 | SESE | | [K891316](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K891316.md) | ANESTHESIA/RESPIRATORY DISPOSABLE MASK | Concord/Portex | Aug 21, 1989 | SESE | | [K884157](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K884157.md) | MODIFIED TOUCH-ME-NOT MASK | Walt'S Products | Aug 21, 1989 | SESE | | [K890795](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K890795.md) | RESPIRONICS SEALEASY II | Respironics, Inc. | Apr 20, 1989 | SESE | | [K890108](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K890108.md) | MODIFIED CUSHION-FLEX(TM) | Life Design Systems, Inc. | Jan 24, 1989 | SESE | | [K884387](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K884387.md) | CUSHION FLEX(TM) | Life Design Systems, Inc. | Nov 17, 1988 | SESE | | [K882434](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ/K882434.md) | MASK, GAS, ANESTHETIC | Eastmed Enterprises, Inc. | Jun 30, 1988 | SESE | ## Top Applicants - Medipart Jerry Alexander — 6 clearances - Life Design Systems, Inc. — 3 clearances - Vital Signs, Inc. — 3 clearances - Engineered Medical Systems — 2 clearances - Hans Rudolph, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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