Product code BYF
- Device name
- Mask, Oxygen, Low Concentration, Venturi
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5600
- 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 |
|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Hospitak, Inc. | 1996-02-28 |
| K951652 | VENTIMASK MK IV | Flexicare Medical, Ltd. | 1995-04-27 |
| K894457 | CARNATION TRACHEOSTOMY MASKS | Dadsun Corp., Ltd. | 1989-10-13 |
| K860873 | VENTURI MASK/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| K860874 | VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| K852618 | OXY-DIAL | Ashai Co. , Ltd. | 1985-09-18 |
| K832725 | DUAL DIAL VENTURI STYLE MASK | Airlife, Inc. | 1983-09-20 |
| K812066 | PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN | Airlife, Inc. | 1981-08-03 |
| K810946 | ADULT & PEDIATRIC TRACHEOSTOMY MASKS | Airlife, Inc. | 1981-06-02 |
| K810947 | AIR ENTRAINMENT TRACH T | Airlife, Inc. | 1981-06-02 |
| K810373 | VENTURI MASK/DELIVERY SYSTEM #'S | Todd Industries, Inc. | 1981-03-17 |
| K810430 | VENTURI MASK/DELIVERY SYSTEM #6078 | Todd Industries, Inc. | 1981-03-13 |
| K790146 | MASK, PERCENTO | Airlife, Inc. | 1979-02-06 |
| K781325 | MARKII VENTIMASKS | Vickers America Medical Corp. | 1978-09-27 |
| K780626 | VENTURI OXYGEN MASK | Hospitak, Inc. | 1978-05-26 |
| K780011 | CONCHAPAK OXYGEN DILUTER | Respiratory Care, Inc. | 1978-02-02 |
| K772127 | OXYGEN MASK, AIR-ENTRAINMENT | Salter Labs | 1978-01-03 |
| K771385 | 2 JET SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-04 |
| K760518 | ADAPTER, PER-CEN-TOX-BODY | Landmark Plastics | 1976-09-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889483569436 | AirLife™ | AIRLIFE | 2025-02-19 |
| 14026704923530 | RUSCH | TELEFLEX INCORPORATED | 2024-04-26 |
| 10888277717831 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-26 |
| 10888277717848 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-26 |
| 10888277717886 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-26 |
| 10080196610877 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-15 |
| 10884389151143 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-13 |
| 10884389966402 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-13 |
| 10884389966419 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-13 |
| 10884389966426 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-13 |
| 10190752116436 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 14026704659460 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-14 |
| 14026704648228 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-09 |
| 14026704648471 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-09 |
| 14026704648464 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-09 |
| 14026704648334 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-09 |
| 14026704648259 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-09 |
| 14026704648211 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-09 |
| 14026704642530 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 14026704642523 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 14026704642516 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 14026704642509 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 00607411300707 | N/A | SALTER LABS | 2016-12-16 |
| 00607411302022 | N/A | SALTER LABS | 2016-12-16 |
| 00607411000331 | n/a | SALTER LABS | 2016-11-30 |
| 00607411000348 | n/a | SALTER LABS | 2016-11-30 |
| 00607411000355 | n/a | SALTER LABS | 2016-11-30 |
| 00607411800191 | n/a | SALTER LABS | 2016-11-30 |
| 00607411800214 | n/a | SALTER LABS | 2016-11-30 |
| 00607411800221 | n/a | SALTER LABS | 2016-11-30 |