Mask, Oxygen, Non-Rebreathing
FDA product code KGB · Class I (low risk) · 21 CFR 868.5570 · Anesthesiology
13510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970688 | Pocket RescueKGB · Traditional | Cheen Houng Ent. Co. , Ltd. | 09/26/1997SE |
| K960401 | Ultimate SealKGB · Traditional | Hans Rudolph, Inc. | 06/20/1996SE |
| K941336 | Combo MaskKGB · Traditional | Gam Industries, Inc. | 09/09/1994SE |
| K935917 | Challenge Powder-Free, Hypoallergenic, Synthetic Surgical GlovesKGB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/04/1994SE |
| K932347 | Compact MaskKGB · Traditional | Vital Signs, Inc. | 01/10/1994SE |
| K933583 | Nonrebreathing ValveKGB · Traditional | Hans Rudolph, Inc. | 01/03/1994SE |
| K933048 | Laerdal(Tm) Pocket Mask, ModificationKGB · Traditional | Laerdal Medical Corp. | 12/02/1993SE |
| K930336 | Profast(R)-Denture Adhesive CreamKGB · Traditional | Fittydent-Altwirth & Schmitt GmbH | 08/24/1993SE |
| K913164 | Non Rebreathing MaskKGB · Traditional | Specialty Packaging Producs, Inc. | 01/15/1992SE |
| K883766 | Mouth-To-Mask Ventilatory AdjunctKGB · Traditional | Medic One | 10/21/1988SE |
| K790162 | Oxygen Mask, Concentration Aerosol MaskKGB · Traditional | Airlife, Inc. | 04/20/1979SE |
| K790161 | Oxygen Mask W/Reservoir BagKGB · Traditional | Airlife, Inc. | 04/20/1979SE |
| K781414 | Mask, Oxygen, NonbreathingKGB · Traditional | Vitalab Products Corp. | 09/07/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0746-2021 Class II | REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female…There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become… | Westmed, Inc. | 11/11/2020Terminated |
| Z-0745-2021 Class II | REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an…There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become… | Westmed, Inc. | 11/11/2020Terminated |
| Z-0744-2021 Class II | REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer…There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become… | Westmed, Inc. | 11/11/2020Terminated |
| Z-0743-2021 Class II | REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X…There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become… | Westmed, Inc. | 11/11/2020Terminated |
| Z-0742-2021 Class II | Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only…There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become… | Westmed, Inc. | 11/11/2020Terminated |
| Z-0741-2021 Class II | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only…There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become… | Westmed, Inc. | 11/11/2020Terminated |