BYE — Attachment, Breathing, Positive End Expiratory Pressure Class II
FDA product code BYE covers "Attachment, Breathing, Positive End Expiratory Pressure", a Class II medical device regulated under 21 CFR 868.5965. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BYE
- Device Class
- Class II
- Regulation Number
- 868.5965
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K160112 | besmed health business | Besmed PEEP Valve | April 29, 2016 |
| K133957 | galemed | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE | April 14, 2014 |
| K133210 | s and t medical technologies | B&B BUBBLER | March 28, 2014 |
| K122610 | sen mu technology co | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES | August 5, 2013 |
| K112546 | o-two medical technologies | O_TWO CPAP SYSTEM | December 27, 2011 |
| K110713 | airways development | WATERPAP VALVE | September 12, 2011 |
| K103833 | neoforce group | NEOPIP PATIENT CIRCUIT WITH PEEP | April 20, 2011 |
| K092029 | draeger medical ag and co. kg | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 | August 6, 2010 |
| K090710 | mercury medical | MERCURY CPAP | August 20, 2009 |
| K090317 | a plus medical | BABI*PLUS BUBBLE PAP VALVE | May 20, 2009 |
| K081266 | mercury enterprizes dba mercury medical | MERCURY MEDICAL PEEP VALVE | March 5, 2009 |
| K080256 | pulmodyne | PULMODYNE CHF FLOW GENERATOR SYSTEM | May 9, 2008 |
| K070416 | neoforce group | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP | May 29, 2007 |
| K050918 | koo americas | KOO AMERICAS VALVE PEEP, MODEL KM-809 | June 6, 2005 |
| K013884 | vygon | BOUSSIGNAC C.P.A.P. DEVICE | January 21, 2003 |
| K001318 | sims portex | CPAP SYSTEM, MODEL 102001 | July 20, 2000 |
| K982283 | caradyne | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN | March 9, 1999 |
| K983920 | engineered medical systems | EMS PEEP VALVES- ADJUSTABLE | January 22, 1999 |
| K981415 | cheen houng ent. co. | 0-20 CM H20 PEEP VALVE | July 14, 1998 |
| K963347 | instrumentation industries | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 | March 19, 1997 |