Besmed PEEP Valve
FDA 510(k) K160112 · Besmed Health Business Corp
510(k) numberK160112
Submission
- Device name
- Besmed PEEP Valve
- Applicant
- Besmed Health Business Corp
New Taipei City, TW - Received
- January 19, 2016
- Decision date
- April 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133957 | Disposable Adjustable Peep Valve MR Conditional UseBYE · Traditional | Galemed Corp. | 04/14/2014SE |
| K133210 | B&B BubblerBYE · Traditional | S & T Medical Technologies, Inc. | 03/28/2014SE |
| K122610 | Plaxtron CPAP System, Model CH-FFM-87XX/CH-FFM-88XX SeriesBYE · Traditional | Sen MU Technology Co., Ltd. | 08/05/2013SE |
| K112546 | O_Two CPAP SystemBYE · Traditional | O-Two Medical Technologies, Inc. | 12/27/2011SE |
| K110713 | Waterpap ValveBYE · Traditional | Airways Development, LLC | 09/12/2011SE |
| K103833 | Neopip Patient Circuit with PeepBYE · Traditional | Neoforce Group, Inc. | 04/20/2011SE |
| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | Draeger Medical AG & Co. KG | 08/06/2010SE |
| K090710 | Mercury CPAPBYE · Traditional | Mercury Medical | 08/20/2009SE |
| K090317 | Babi*Plus Bubble Pap ValveBYE · Traditional | A Plus Medical | 05/20/2009SE |
| K081266 | Mercury Medical Peep ValveBYE · Traditional | Mercury Enterprizes Dba Mercury Medical | 03/05/2009SE |
More from Mercury Enterprizes Dba Mercury Medical
| 510(k) | Device | Decision |
|---|---|---|
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | 11/14/2024SE |
| K172804 | Besmed Peak Flow MeterBZH · Traditional | 01/11/2018SE |
| K150591 | Besmed Reusable Jet NebulizerCAF · Traditional | 06/30/2015SE |
| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | 02/05/2015SE |
| K141355 | Volumetric Incentive SpirometerBWF · Traditional | 09/03/2014SE |
| 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 Besmed PEEP Valve cleared by the FDA?
Besmed PEEP Valve (K160112) received a 510(k) decision of Substantially Equivalent on April 29, 2016, 101 days after the submission was received.
What is the product code of K160112?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.