Bio-Detek, Inc.
Medical device manufacturer in Pawtucket, RI.
17510(k) clearances
0PMA approvals
11recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelMKJ · Traditional | 05/02/2015SE |
| K150055 | OneStep Pediatric CPR Multi-Function ElectrodeMKJ · Traditional | 05/02/2015SE |
| K133441 | Onestep CPR II Multi-Function ElectrodeMKJ · Traditional | 10/10/2014SE |
| K100565 | Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300…MKJ · Traditional | 11/16/2010SE |
| K071321 | PocketcprLIX · Traditional | 09/12/2007SE |
| K040256 | Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005MKJ · Traditional | 04/09/2004SE |
| K040056 | Bio-Detek Electrode Adapter, Model R2001-90MKJ · Traditional | 04/09/2004SE |
| K033771 | Bio-Detek Modified Adult Multi-Function Electrode with ConnectorMKJ · Traditional | 02/27/2004SE |
| K984582 | Zoll Superpadz Adult Multi-Function Electrodes, Model 8900-XXXXMKJ · Traditional | 03/16/1999SE |
| K990106 | Zoll First Responder Padz Adult Defibrillation ElectrodesMKJ · Traditional | 02/26/1999SE |
| K981802 | Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003MKJ · Traditional | 11/25/1998SE |
| K964213 | Trace Rite Solid Gel ECG ElectrodesDRX · Traditional | 11/25/1996SE |
| K920352 | Bio-Detek EEG ElectrodeGXZ · Traditional | 08/14/1992SE |
| K920264 | Bio-Detek Tracerite EEG ElectrodeGXY · Traditional | 06/02/1992SE |
| K912714 | RT40 Radio TranslucentDRX · Traditional | 07/25/1991SE |
| K853038 | DE12 Rapid Trace At-Rest Diagnostic ECG ElectrodesDRX · Traditional | 01/07/1986SE |
| K853291 | GP-100 Adult Electrosurgical Ground PAD/200 & 300HAM · Traditional | 10/10/1985SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1945-2019 Class II | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and…Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing… | 05/28/2019Terminated |
| Z-0055-2015 Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1…Product sterility is not assured | 09/16/2014Terminated |
| Z-0054-2015 Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part…Product sterility is not assured | 09/16/2014Terminated |
| Z-0053-2015 Class II | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013…Product sterility is not assured | 09/16/2014Terminated |
| Z-0052-2015 Class II | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product…Product sterility is not assured | 09/16/2014Terminated |
| Z-2660-2014 Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part…Sterility of device is not assured | 08/26/2014Terminated |
| Z-2659-2014 Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013…Sterility of device is not assured | 08/26/2014Terminated |
| Z-2658-2014 Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE…Sterility of device is not assured | 08/26/2014Terminated |
| Z-2565-2014 Class II | Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak…Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could… | 03/12/2013Terminated |
| Z-1011-2012 | Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401…Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter. | 12/30/2011Terminated |
| Z-2334-2008 | ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The…Multi-function electrode programmed as a Pediatric instead of Adult | 06/16/2008Terminated |