Voflex
FDA 510(k) K840239 · Dhd Medical Products Div. Diemolding Corp.
510(k) numberK840239
Submission
- Device name
- Voflex
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
Mchenry, IL, US - Received
- January 20, 1984
- Decision date
- March 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K883988 | Non-Rebreathing Tee Piece (NRTP)CBP · Traditional | 10/07/1988SE |
| K881935 | Microcirrus Medical NebulizerCAF · Traditional | 06/22/1988SE |
| K881178 | CuffcheckBSK · Traditional | 04/14/1988SE |
| K873498 | Inspiratory Force Mont Kit/Manifold/Meter/TubingBXR · Traditional | 03/09/1988SE |
| K874047 | AsthmakitCAF · Traditional | 02/29/1988SE |
| K873447 | Disposable Condensate Bottle for 7200 VentilatorBYH · Traditional | 10/30/1987SE |
| K860885 | Straight Connectors, 15MM, 30MM & 19MMBZA · Traditional | 03/20/1986SE |
| K860882 | Disposable CatheterBZA · Traditional | 03/20/1986SE |
| K860880 | Ventilator Circuits (Various Types)BZO · Traditional | 03/20/1986SE |
| K860879 | Disposable Ventilator CircuitsBZO · Traditional | 03/20/1986SE |
Questions and answers
When was Voflex cleared by the FDA?
Voflex (K840239) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 45 days after the submission was received.
What is the product code of K840239?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.