BSJ · Mask, Gas, Anesthetic
Anesthesiology · 21 CFR 868.5550 · Class 1
Overview
| Product Code | BSJ |
|---|---|
| Device Name | Mask, Gas, Anesthetic |
| Regulation | 21 CFR 868.5550 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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 | SuperNO2VA Device | Revolutionary Medical Devices, Inc. | Oct 13, 2017 | SESE |
| K953107 | ANESTHESIA/RESPIRATORY FACE MASK | Medical Marketing Concepts | Aug 15, 1995 | SESE |
| K953295 | ANESTHESIA FACE MASK | Mallinckrodt Medical | Aug 11, 1995 | SESE |
| K952689 | BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK | Owens-Brigam Medical Co. | Jul 11, 1995 | SESE |
| K951043 | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK | Promedic, Inc. | Jun 7, 1995 | SESE |
| K950771 | DISPOSABLE ADHESIVE FACE MASK | Advanced Warming Systems, Inc. | Mar 10, 1995 | SESE |
| K945894 | MASK, GAS, ANESTHETIC | Hans Rudolph, Inc. | Jan 27, 1995 | SESE |
| K945440 | DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK | Fvtnks | Nov 8, 1994 | SESE |
| K944157 | DISPOSABLE, PREFORMED FACE MASK | Meridian Medical Systems, Inc. | Oct 3, 1994 | SESE |
| K932147 | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE | Hans Rudolph, Inc. | Aug 20, 1993 | SESE |
| K932014 | AMBU DISPOSABLE FACE MASK | Ambu, Inc. | Jun 22, 1993 | SESE |
| K915558 | IAS ANESTHESIA MASK | Ias | Apr 8, 1992 | SESE |
| K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 | Ventlab Corp. | Sep 4, 1990 | SESE |
| K902298 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS | Rondex Products, Inc. | Aug 22, 1990 | SESE |
| K891316 | ANESTHESIA/RESPIRATORY DISPOSABLE MASK | Concord/Portex | Aug 21, 1989 | SESE |
| K884157 | MODIFIED TOUCH-ME-NOT MASK | Walt'S Products | Aug 21, 1989 | SESE |
| K890795 | RESPIRONICS SEALEASY II | Respironics, Inc. | Apr 20, 1989 | SESE |
| K890108 | MODIFIED CUSHION-FLEX(TM) | Life Design Systems, Inc. | Jan 24, 1989 | SESE |
| K884387 | CUSHION FLEX(TM) | Life Design Systems, Inc. | Nov 17, 1988 | SESE |
| K882434 | 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
