Volumetric Incentive Spirometer
FDA 510(k) K141355 · Besmed Health Business Corporation
510(k) numberK141355
Submission
- Device name
- Volumetric Incentive Spirometer
- Applicant
- Besmed Health Business Corporation
New Taipei City, TW - Received
- May 23, 2014
- Decision date
- September 3, 2014
- 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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| 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 |
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|---|---|---|
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| K172804 | Besmed Peak Flow MeterBZH · Traditional | 01/11/2018SE |
| K160112 | Besmed PEEP ValveBYE · Traditional | 04/29/2016SE |
| K150591 | Besmed Reusable Jet NebulizerCAF · Traditional | 06/30/2015SE |
| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | 02/05/2015SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | 06/19/2014SE |
| K133873 | Triball Incentive SpirometerBWF · Traditional | 04/04/2014SE |
| K091272 | Besmed Jet Nebulizer Bottle SetCAF · Traditional | 11/10/2009SE |
| K031374 | Besmed Various Models of TENS, BE-550/BE-660GZJ · Traditional | 11/28/2003SE |
| K031375 | Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580IPF · Traditional | 11/20/2003SE |
Questions and answers
When was Volumetric Incentive Spirometer cleared by the FDA?
Volumetric Incentive Spirometer (K141355) received a 510(k) decision of Substantially Equivalent on September 3, 2014, 103 days after the submission was received.
What is the product code of K141355?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.