Ackrad Pediatric C.P.A.P. System
FDA 510(k) K880161 · Ackrad Laboratories
510(k) numberK880161
Submission
- Device name
- Ackrad Pediatric C.P.A.P. System
- Applicant
- Ackrad Laboratories
Cranford, NJ, US - Received
- January 13, 1988
- Decision date
- March 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K160112 | Besmed PEEP ValveBYE · Traditional | Besmed Health Business Corp | 04/29/2016SE |
| 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 |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K021272 | Sib Catheter, Model 61-7005LKF · Special | 05/21/2002SE |
| K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…LKF · Special | 04/24/2002SE |
| K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007LKF · Special | 04/16/2002SE |
| K970492 | Intrauterine Insemination and Sonohysterography CatheterLKF · Traditional | 04/09/1997SE |
| K961752 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/08/1996SE |
| K952542 | Ackrad Esophageal Balloon Catheter SetBZC · Traditional | 04/23/1996SE |
| K940176 | Ackrad Iui Set for Intrauterine InseminationMFD · Traditional | 04/23/1996SE |
| K953034 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/29/1995SE |
| K915813 | Ackrad Ercp Contrast Delivery SetFGE · Traditional | 03/11/1992SE |
| K904499 | Nicos (Non-Invasive Cardiac Output System)KFG · Traditional | 07/01/1991SE |
Questions and answers
When was Ackrad Pediatric C.P.A.P. System cleared by the FDA?
Ackrad Pediatric C.P.A.P. System (K880161) received a 510(k) decision of Substantially Equivalent on March 4, 1988, 51 days after the submission was received.
What is the product code of K880161?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.