Mask, Gas, Anesthetic
FDA product code BSJ · Class I (low risk) · 21 CFR 868.5550 · Anesthesiology
51510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Medipart Jerry Alexander 6
- Vital Signs, Inc. 3
- Life Design Systems, Inc. 3
- Rondex Products, Inc. 2
- Hans Rudolph, Inc. 2
- Engineered Medical Systems 2
- Warne Surgical Products, Ltd. 2
- Ohio Medical Products 2
- Marquest Medical Products, Inc. 1
- Hospitak, Inc. 1
- Dryden Corp. 1
- Medovations, Inc. 1
- Plasmedics, Inc. 1
- Anesthesia Respiratory Technology, Inc. 1
- Med Systems 1
- Loran , Ltd. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Brigam, Inc. 1
- Revolutionary Medical Devices, Inc. 1
- Parker Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163277 | SuperNO2VA DeviceBSJ · Traditional | Revolutionary Medical Devices, Inc. | 10/13/2017SE |
| K953107 | Anesthesia/Respiratory Face MaskBSJ · Traditional | Medical Marketing Concepts | 08/15/1995SE |
| K953295 | Anesthesia Face MaskBSJ · Traditional | Mallinckrodt Medical | 08/11/1995SE |
| K952689 | Brigam Medical Disposable Anesthesia/Respiratory Face MaskBSJ · Traditional | Owens-Brigam Medical Co. | 07/11/1995SE |
| K951043 | Air-Soft-Disposable, Anesthesisa/Respiratory Face MaskBSJ · Traditional | Promedic, Inc. | 06/07/1995SE |
| K950771 | Disposable Adhesive Face MaskBSJ · Traditional | Advanced Warming Systems, Inc. | 03/10/1995SE |
| K945894 | Mask, Gas, AnestheticBSJ · Traditional | Hans Rudolph, Inc. | 01/27/1995SE |
| K945440 | Disposable, Anesthesia/Respiratory Face MaskBSJ · Traditional | Fvtnks | 11/08/1994SE |
| K944157 | Disposable, Preformed Face MaskBSJ · Traditional | Meridian Medical Systems, Inc. | 10/03/1994SE |
| K932147 | Non Conductive Anesthesia Face Mask,SiliconeBSJ · Traditional | Hans Rudolph, Inc. | 08/20/1993SE |
| K932014 | Ambu Disposable Face MaskBSJ · Traditional | Ambu, Inc. | 06/22/1993SE |
| K915558 | Ias Anesthesia MaskBSJ · Traditional | Ias | 04/08/1992SE |
| K903881 | Ventlab Vent-Mask, Cat# VR 0010/20/30BSJ · Traditional | Ventlab Corp. | 09/04/1990SE |
| K902298 | Oral-Nasal Mask Resuscitation and Anesthetic GasBSJ · Traditional | Rondex Products, Inc. | 08/22/1990SE |
| K891316 | Anesthesia/Respiratory Disposable MaskBSJ · Traditional | Concord/Portex | 08/21/1989SE |
| K884157 | Modified Touch-Me-Not MaskBSJ · Traditional | Walt'S Products | 08/21/1989SE |
| K890795 | Respironics Sealeasy IIBSJ · Traditional | Respironics, Inc. | 04/20/1989SE |
| K890108 | Modified Cushion-Flex(Tm)BSJ · Traditional | Life Design Systems, Inc. | 01/24/1989SE |
| K884387 | Cushion Flex(Tm)BSJ · Traditional | Life Design Systems, Inc. | 11/17/1988SE |
| K882434 | Mask, Gas, AnestheticBSJ · Traditional | Eastmed Enterprises, Inc. | 06/30/1988SE |
| K881393 | Rondex Rescue MaskBSJ · Traditional | Rondex Products, Inc. | 04/25/1988SE |
| K881067 | Non Conductive, Single Use Anesthesia Face MaskBSJ · Traditional | Medesign, Inc. | 03/24/1988SE |
| K880682 | Mask, Anesth. Inflatable & Pediatric Scented, DispBSJ · Traditional | King Systems Corp. | 03/21/1988SE |
| K874746 | Sealflex MaskBSJ · Traditional | Engineered Medical Systems | 12/21/1987SE |
| K872015 | Spiraseal(Tm) Face Mask (Various Sizes)BSJ · Traditional | Brigam, Inc. | 06/17/1987SE |
| K871851 | Ribbed Cushion MaskBSJ · Traditional | Engineered Medical Systems | 06/08/1987SE |
| K862784 | Mp-Xmo Disposable Face MaskBSJ · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862783 | Mp-Xmv Disposable Face MaskBSJ · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862782 | Mp-Xml Disposable Face MaskBSJ · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862781 | Mp-Xmm Disposable Face MaskBSJ · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K860686 | Faceglov,Anesthetic Gas MaskBSJ · Traditional | Loran , Ltd. | 04/30/1986SE |
| K853785 | Series 2000 Meds MaskBSJ · Traditional | Med Systems | 12/03/1985SE |
| K854161 | Sur-Fit Face MaskBSJ · Traditional | Anesthesia Respiratory Technology, Inc. | 11/05/1985SE |
| K850263 | Pediatric Anesthesia Mask W/Pacifier/Ring AssemblyBSJ · Traditional | Plasmedics, Inc. | 03/25/1985SE |
| K844494 | Medipart Face Mask Mp-XmBSJ · Traditional | Medipart Jerry Alexander | 12/04/1984SE |
| K844493 | Medipart Face Mask & Filter MP-30XMBSJ · Traditional | Medipart Jerry Alexander | 12/04/1984SE |
| K843169 | Cushion-Flex TMBSJ · Traditional | Life Design Systems, Inc. | 08/20/1984SE |
| K842472 | Dryden Inflatable MaskBSJ · Traditional | Dryden Corp. | 07/06/1984SE |
| K841240 | Disposable Anesthesia MaskBSJ · Traditional | Hospitak, Inc. | 04/05/1984SE |
| K840535 | Dispos. Anesthesia Face MaskBSJ · Traditional | Marquest Medical Products, Inc. | 02/21/1984SE |
| K840452 | Premium Dabm Dispos. Anes. Breath MaskBSJ · Traditional | Ohio Medical Products | 02/17/1984SE |
| K834536 | Crystalcone Face Mask-Med-W/HookringBSJ · Traditional | Warne Surgical Products, Ltd. | 01/25/1984SE |
| K834454 | Paediatric Face Mask 1-3 W/Wo RingBSJ · Traditional | Warne Surgical Products, Ltd. | 01/18/1984SE |
| K831713 | Non Conductive Anesthesia FacemaskBSJ · Traditional | Vital Signs, Inc. | 07/07/1983SE |
| K830982 | MasksBSJ · Traditional | Medovations, Inc. | 05/09/1983SE |
| K821045 | Non Conductive Pediatric Anes. FaceBSJ · Traditional | Vital Signs, Inc. | 04/26/1982SE |
| K810990 | Ohio Nonconductive RBS Type Face MaskBSJ · Traditional | Ohio Medical Products | 04/23/1981SE |
| K803185 | Non-Conductive Anesthesia Face MaskBSJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/05/1981SE |
| K801251 | Non-Conductive, Single Use Face Mask #55BSJ · Traditional | Vital Signs, Inc. | 06/04/1980SE |
| K790638 | Accutron Pollution ReducerBSJ · Traditional | Parker Laboratories, Inc. | 05/25/1979SE |
| K782163 | The Blue MaskBSJ · Traditional | Collectovac, Inc. | 03/01/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1058-2013 Class I | Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory…The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling… | Engineered Medical Systems,Inc | 09/12/2011Terminated |