Product code BWF
- Device name
- Spirometer, Therapeutic (Incentive)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5690
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241152 | InSee | Tidal Medical Technologies, LLC | 2025-08-21 |
| K233855 | AllPEP | Enchant Tek Co. , Ltd. | 2024-02-02 |
| K221058 | LungTrainer (MD2 & MD3) | Lung Trainers, LLC | 2023-07-05 |
| K222018 | Breathe+ | Peep Medical, LLC Dba Go2 Devices | 2023-06-02 |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | 2022-10-25 |
| K203378 | Pulsehaler | Respinova, Ltd. | 2021-03-31 |
| K192000 | D R Burton OxyPAP | D R Burton Healthcare, LLC | 2020-02-19 |
| K181660 | Acapella Choice Blue Vibratory PEP Device | Smiths Medical | 2019-10-24 |
| K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019-08-16 |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | 2019-07-01 |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | 2018-08-17 |
| K172388 | VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017-12-22 |
| K160837 | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM | Medinet Srl | 2017-02-23 |
| K163091 | VibraPEP | Medica Holdings, LLC | 2017-02-21 |
| K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | 2016-08-03 |
| K150044 | O-PEP | Pari Respiratory Equipment, Inc. | 2016-05-27 |
| K153441 | VibraPEP | Medica Holdings, LLC | 2016-03-25 |
| K150173 | Aerobika OPEP Devive with Manometer | Trudell Medical International | 2015-10-15 |
| K140772 | AEROSURE MEDIC | Actegy , Ltd. | 2014-12-19 |
| K141355 | VOLUMETRIC INCENTIVE SPIROMETER | Besmed Health Business Corporation | 2014-09-03 |
| K133873 | TRIBALL INCENTIVE SPIROMETER | Besmed Health Business Corp | 2014-04-04 |
| K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | Trudell Medical Intl. | 2013-05-16 |
| K091557 | LUNG FLUTE THERAPEUTIC | Medical Acoustics | 2010-01-04 |
| K090829 | PARI PEP S | Pari Respiratory Equipment, Inc. | 2009-07-21 |
| K080299 | RESPIFIT S, MODEL RS-LR1001004 | Eumedics Medizintechnik Und Marketing GmbH | 2009-01-13 |
| K070490 | CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) | Advanced Circulatory Systems, Inc. | 2007-06-20 |
| K053149 | SPIRO-BALL | Leventon, S.A. | 2005-12-13 |
| K040084 | LIFESTYLE CIRCULATORY ENHANCER | Advanced Circulatory Systems, Inc. | 2004-04-07 |
| K033401 | MODIFICATION TO RESQPOD CIRCULATORY ENHANCER | Advanced Circulatory Systems, Inc. | 2003-11-20 |
| K022906 | RESQPOD CIRCULATORY ENHANCER | Cprx, LLC | 2003-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344010332 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-01-23 |
| 10197344010349 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-01-23 |
| 10197344010356 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-01-23 |
| 10197344097715 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-07-23 |
| 10612479269948 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2024-05-14 |
| 10612479269924 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2024-05-14 |
| 10612479269900 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2024-05-14 |
| 10197344007691 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2023-12-18 |
| 10190752117167 | AirLife™ | AIRLIFE | 2021-04-02 |
| 10190752131071 | AirLife™ | AIRLIFE | 2021-03-26 |
| 10190752131064 | AirLife | AIRLIFE | 2020-01-31 |
| 10190752144774 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-17 |
| 08436020761843 | SPIRO-BALL | LEVENTON SAU | 2017-06-12 |
| 08436020761836 | TRI-BALL | LEVENTON SAU | 2017-06-12 |
| 10788942220058 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942220003 | Medex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942215306 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942212008 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942211124 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942211100 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942210158 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942207578 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942207479 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942201200 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942200500 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942200227 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942200104 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942200050 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10351688404008 | Portex | ICU MEDICAL, INC. | 2016-10-05 |
| 10641043370018 | Resistex | MERCURY ENTERPRISES, INC. | 2016-03-02 |