Acapella
FDA 510(k) K002768 · Dhd Healthcare Corp.
510(k) numberK002768
Submission
- Device name
- Acapella
- Applicant
- Dhd Healthcare Corp.
Wampsville, NY, US - Received
- September 6, 2000
- Decision date
- December 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
Other 510(k)s with product code BWF
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|---|---|---|---|
| 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 |
|---|---|---|
| K040718 | TrustCAF · Traditional | 04/02/2004SE |
| K003146 | Cliniflo Incentive SpirometerBWF · Traditional | 11/21/2000SE |
| K991561 | Roadrunner, Pep Therapy DeviceBWF · Traditional | 11/10/1999SE |
| K991300 | Boeing, Positive Airway Pressure (Pap) Therapy DeviceBWF · Traditional | 07/12/1999SE |
| K983467 | TherapepBWF · Traditional | 04/02/1999SE |
| K980662 | Lichen, Bacterial in Line Breathing FilterCAH · Traditional | 09/14/1998SE |
| K981167 | Stealth Pilot Kit/ Stealth Spacer/Face Mask KitCAF · Traditional | 06/18/1998SE |
Questions and answers
When was Acapella cleared by the FDA?
Acapella (K002768) received a 510(k) decision of Substantially Equivalent on December 5, 2000, 90 days after the submission was received.
What is the product code of K002768?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.