Aeropep
FDA 510(k) K012368 · Trudell Medical Intl.
510(k) numberK012368
Submission
- Device name
- Aeropep
- Applicant
- Trudell Medical Intl.
London, CA - Received
- July 26, 2001
- Decision date
- February 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241152 | InSeeBWF · Traditional | Tidal Medical Technologies, LLC | 08/21/2025SE |
| K233855 | AllPEPBWF · Traditional | Enchant Tek Co. , Ltd. | 02/02/2024SE |
| K221058 | LungTrainer (MD2 & MD3)BWF · Traditional | Lung Trainers, LLC | 07/05/2023SE |
| K222018 | Breathe+BWF · Traditional | Peep Medical, LLC Dba Go2 Devices | 06/02/2023SE |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional | Medline Industries, Inc. | 10/25/2022SE |
| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131881 | Ombra Table Top CompressorBTI · Traditional | 10/24/2013SE |
| K123400 | Aerobika Positive Expiratory Pressure DeviceBWF · Traditional | 05/16/2013SE |
| K123614 | Solarys Ventilator Aerosol Delivery System (AS)CAF · Traditional | 03/11/2013SE |
| K112010 | Aerochamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC)NVP · Traditional | 07/11/2012SE |
| K110136 | Respichamber Valved Holding ChamberNVP · Traditional | 04/18/2011SE |
| K090065 | Aerochamber Mini Ventilation ChamberCAF · Traditional | 04/09/2009SE |
| K080926 | Aeroeclipse Durable Breath Actuated NebulizerCAF · Traditional | 08/12/2008SE |
| K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-Vu Inspiratory Flow…NVP · Special | 04/11/2007SE |
| K053605 | Aeroeclipse II Breath Actuated NebulizerCAF · Special | 02/27/2006SE |
| K052332 | Aerochamber Z-Stat Plus Valved Holding ChamberNVP · Special | 09/21/2005SE |
Questions and answers
When was Aeropep cleared by the FDA?
Aeropep (K012368) received a 510(k) decision of Substantially Equivalent on February 12, 2002, 201 days after the submission was received.
What is the product code of K012368?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.