Product code BSJ
- Device name
- Mask, Gas, Anesthetic
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5550
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163277 | SuperNO2VA Device | Revolutionary Medical Devices, Inc. | 2017-10-13 |
| K953107 | ANESTHESIA/RESPIRATORY FACE MASK | Medical Marketing Concepts | 1995-08-15 |
| K953295 | ANESTHESIA FACE MASK | Mallinckrodt Medical | 1995-08-11 |
| K952689 | BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK | Owens-Brigam Medical Co. | 1995-07-11 |
| K951043 | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK | Promedic, Inc. | 1995-06-07 |
| K950771 | DISPOSABLE ADHESIVE FACE MASK | Advanced Warming Systems, Inc. | 1995-03-10 |
| K945894 | MASK, GAS, ANESTHETIC | Hans Rudolph, Inc. | 1995-01-27 |
| K945440 | DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK | Fvtnks | 1994-11-08 |
| K944157 | DISPOSABLE, PREFORMED FACE MASK | Meridian Medical Systems, Inc. | 1994-10-03 |
| K932147 | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE | Hans Rudolph, Inc. | 1993-08-20 |
| K932014 | AMBU DISPOSABLE FACE MASK | Ambu, Inc. | 1993-06-22 |
| K915558 | IAS ANESTHESIA MASK | Ias | 1992-04-08 |
| K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 | Ventlab Corp. | 1990-09-04 |
| K902298 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS | Rondex Products, Inc. | 1990-08-22 |
| K891316 | ANESTHESIA/RESPIRATORY DISPOSABLE MASK | Concord/Portex | 1989-08-21 |
| K884157 | MODIFIED TOUCH-ME-NOT MASK | Walt'S Products | 1989-08-21 |
| K890795 | RESPIRONICS SEALEASY II | Respironics, Inc. | 1989-04-20 |
| K890108 | MODIFIED CUSHION-FLEX(TM) | Life Design Systems, Inc. | 1989-01-24 |
| K884387 | CUSHION FLEX(TM) | Life Design Systems, Inc. | 1988-11-17 |
| K882434 | MASK, GAS, ANESTHETIC | Eastmed Enterprises, Inc. | 1988-06-30 |
| K881393 | RONDEX RESCUE MASK | Rondex Products, Inc. | 1988-04-25 |
| K881067 | NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK | Medesign, Inc. | 1988-03-24 |
| K880682 | MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP | King Systems Corp. | 1988-03-21 |
| K874746 | SEALFLEX MASK | Engineered Medical Systems | 1987-12-21 |
| K872015 | SPIRASEAL(TM) FACE MASK (VARIOUS SIZES) | Brigam, Inc. | 1987-06-17 |
| K871851 | RIBBED CUSHION MASK | Engineered Medical Systems | 1987-06-08 |
| K862784 | MP-XMO DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 |
| K862782 | MP-XML DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 |
| K862781 | MP-XMM DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 |
| K862783 | MP-XMV DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253071405 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-04-06 |
| 10192253071467 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-03-23 |
| 10192253071450 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-03-23 |
| 10192253071443 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-03-23 |
| 10192253071436 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-03-23 |
| 10192253071429 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-03-23 |
| 10192253071412 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-03-23 |
| 10193489135374 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-24 |
| 10193489135367 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-24 |
| 10193489135381 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-24 |
| 10197344097258 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10197344097180 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10197344097197 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10197344097203 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10197344097210 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10197344097227 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10197344097234 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10197344097241 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-23 |
| 10195327334161 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-02-05 |
| H66860701701 | Mizzy Comfort Cushion | Keystone Industries | 2022-11-30 |
| H66860701651 | Mizzy Comfort Cushion | Keystone Industries | 2022-11-30 |
| 10190752147294 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2022-09-05 |
| 10190752146327 | AirLife™ | AIRLIFE | 2022-08-22 |
| 10190752146310 | AirLife™ | AIRLIFE | 2022-08-22 |
| 10080196410958 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-29 |
| 10080196323715 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-26 |
| 10080196410965 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-25 |
| 10080196410941 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-25 |
| 10190752145450 | SuperNO2VA | AIRLIFE | 2020-01-15 |
| 10190752145436 | SuperNO2VA | AIRLIFE | 2020-01-15 |