Expiratory Breathing Exerciser
FDA 510(k) K945118 · Dhd Diemolding Healthcare Div.
510(k) numberK945118
Submission
- Device name
- Expiratory Breathing Exerciser
- Applicant
- Dhd Diemolding Healthcare Div.
Wampsville, NY, US - Received
- October 18, 1994
- Decision date
- January 13, 1995
- 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
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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 |
|---|---|---|
| K973532 | Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral ActuatorCAF · Traditional | 03/19/1998SE |
| K970596 | DHD Emerald ProductBWF · Traditional | 05/16/1997SE |
| K961973 | DHD Ace with Mask KitCAF · Traditional | 08/15/1996SE |
| K953206 | DHD Metered Dose Inhaler (Mdi) Spacer (Modification)CAF · Traditional | 08/28/1995SE |
| K944900 | TherapepBWF · Traditional | 01/06/1995SE |
| K926301 | Ace Aerosol Enhancer, Hand Held Oral Inhalation CoCAF · Traditional | 07/21/1993SE |
| K922537 | DuralifeBZA · Traditional | 12/04/1992SE |
| K913726 | Duralife(Tm)BZA · Traditional | 02/07/1992SE |
| K913326 | DHD Metered Dose Inhaler (Mdi) SpacerCAF · Traditional | 01/07/1992SE |
| K911294 | Ultraset CatheterBZA · Traditional | 06/10/1991SE |
Questions and answers
When was Expiratory Breathing Exerciser cleared by the FDA?
Expiratory Breathing Exerciser (K945118) received a 510(k) decision of Substantially Equivalent on January 13, 1995, 87 days after the submission was received.
What is the product code of K945118?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.