Product code BYG
- Device name
- Mask, Oxygen
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5580
- 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 |
|---|---|---|---|
| K963298 | FIRST AID KIT(S) | Vector, Inc. | 1996-11-06 |
| K962848 | HANS RUDOLPH NASAL CPAP MASK | Hans Rudolph, Inc. | 1996-10-16 |
| K945482 | DISPOSABLE, CPAP OXYGEN MASK | Fvtnks | 1995-09-19 |
| K953464 | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | Westmed, Inc. | 1995-09-18 |
| K953039 | VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS | Dadsun Corp., Ltd. | 1995-09-15 |
| K945472 | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | Westmed Intl. | 1995-02-07 |
| K942907 | JEMSDAL MASK | Respan Products, Inc. | 1994-08-31 |
| K940887 | SYSTEM 22 ADULT MASK | Medic-Aid , Ltd. | 1994-04-19 |
| K940888 | SYSTEM 22 PAEDIATRIC MASK | Medic-Aid , Ltd. | 1994-04-19 |
| K931952 | MEDWAY OXYGEN MASK | Medway | 1993-08-20 |
| K924069 | SURGICO OXYGEN MASK | Gujarat Surgico, Ltd. | 1993-02-04 |
| K921499 | SEAL RING FOR NASAL CPAP | Devilbiss Health Care, Inc. | 1992-09-17 |
| K913501 | TRACHEOSTOMY MASK | B & F Medical Products, Inc. | 1992-01-13 |
| K913383 | OXYGEN MASKS 81420, 81421, 81471 & 81461 | Specialty Packaging Producs, Inc. | 1991-10-18 |
| K913275 | VENTURI OXYGEN MASK | Specialty Packaging Producs, Inc. | 1991-10-10 |
| K913455 | OXYGEN MASKS 82400 & 82405 | Specialty Packaging Producs, Inc. | 1991-10-02 |
| K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | Salter Labs | 1991-07-19 |
| K905288 | ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES | Med-Tek Innovations, Inc. | 1991-04-09 |
| K904719 | DISPOSABLE FACE MASK | Tri/Bor Medical, Inc. | 1991-01-02 |
| K904195 | DISPOSABLE FACE MASK | Bp , Ltd. | 1990-09-25 |
| K896773 | DISPOSABLE FACE MASK | Cadema Medical Products, Inc. | 1990-01-12 |
| K894642 | SLEEPAP MASK | Medical Industries America, Inc. | 1989-10-19 |
| K892434 | KENDALL CURITY OXYGEN MASK | The Kendal Co. | 1989-08-15 |
| K890193 | SINGLE PATIENT USE NASAL (CPAP) CIRCUIT | Puritan Bennett Corp. | 1989-03-14 |
| K874092 | MASK, OXYGEN | Life Support Products, Inc. | 1988-02-11 |
| K870206 | CRYSTAL MASK | Brunswick Mfg. Co., Inc. | 1987-02-20 |
| K865047 | SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE | Salter Labs | 1987-02-10 |
| K860869 | MEDIUM CONCENTRATION OXYGEN MASKS | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| K860870 | AEROSOL MASKS/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| K860871 | TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840118621137 | Endure Industries | ENDURE INDUSTRIES | 2026-08-17 |
| 00840118621144 | Endure Industries | ENDURE INDUSTRIES | 2026-08-14 |
| 00848530108717 | Nasal CPAP Mask | Sunset Healthcare Solutions, Inc. | 2026-04-07 |
| 00848530108724 | Nasal CPAP Mask | Sunset Healthcare Solutions, Inc. | 2026-04-07 |
| 00848530107482 | Replacement Headgear Clips for Sunset Vesper Full Face CPAP Mask | Sunset Healthcare Solutions, Inc. | 2025-10-15 |
| 00848530107475 | Replacement Clips for Sol Full Face CPAP Mask | Sunset Healthcare Solutions, Inc. | 2025-10-15 |
| 00848530106454 | CPAP Mask | Sunset Healthcare Solutions, Inc. | 2025-07-22 |
| 00848530105433 | Cough Assist | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530097172 | CPAP Mask | Sunset Healthcare Solutions, Inc. | 2025-05-19 |
| 00848530040307 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-08-01 |
| 00848530040291 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-08-01 |
| 00848530040314 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-08-01 |
| 00848530104214 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-08-01 |
| 00848530104221 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-08-01 |
| 00848530096281 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-06-24 |
| 00848530096304 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-06-24 |
| 00848530097059 | Oxygen Mask | Sunset Healthcare Solutions, Inc. | 2024-06-24 |
| 00848530096298 | Oxygen Mask | Sunset Healthcare Solutions, Inc. | 2024-06-22 |
| 00848530104276 | Oxygen Masks | Sunset Healthcare Solutions, Inc. | 2024-06-15 |
| 00848530101770 | Mask for SperaChamber Size Medium (Pediatric) | Sunset Healthcare Solutions, Inc. | 2024-03-05 |
| 00848530101787 | Mask for SperaChamber Size Small (Infant) | Sunset Healthcare Solutions, Inc. | 2024-03-05 |
| 00848530101763 | Mask for SperaChamber Size Large (Adult) | Sunset Healthcare Solutions, Inc. | 2024-03-05 |
| 00840155400412 | MedSource Oxygen Mask | MEDSOURCE INTERNATIONAL LLC | 2021-05-28 |
| 00840155400375 | MedSource Oxygen Mask | MEDSOURCE INTERNATIONAL LLC | 2021-05-28 |
| 00840117308558 | Resp-O2 Aerosol Standard Adult Mask | Dynarex Corporation | 2021-04-22 |
| 00840117308572 | Resp-O2 Aerosol Elongated Masks, Adult | Dynarex Corporation | 2021-04-22 |
| 00840117311732 | Resp-O2 Aerosol Standard Mask, Pediatric | Dynarex Corporation | 2021-04-22 |
| 00840117311756 | Resp-O2 Aerosol Standard Mask, Infant | Dynarex Corporation | 2021-01-19 |
| 00848530060947 | Adult Simple Oxygen Mask w/7' Safety Tubing | Sunset Healthcare Solutions, Inc. | 2018-09-24 |
| 00848530060985 | Tracheostomy Mask w/ O2 connector - Adult | Sunset Healthcare Solutions, Inc. | 2018-09-19 |