Company ยท US
Bio-Detek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2015. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 18 |
| DRX | Electrode, Electrocardiograph | 3 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 |
| GXY | Electrode, Cutaneous | 1 |
| GXZ | Electrode, Needle | 1 |
| HAM | Apparatus, Electrosurgical | 1 |
| LIX | Aid, Cardiopulmonary Resuscitation | 1 |
| MLN | Electrode, Electrocardiograph, Multi-Function | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2015 | K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel Bio-Detek, Inc. | MKJ |
| May 2, 2015 | K150055 | OneStep Pediatric CPR Multi-Function Electrode Bio-Detek, Inc. | MKJ |
| Oct 10, 2014 | K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE Bio-Detek, Inc. | MKJ |
| Nov 16, 2010 | K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 Bio-Detek, Inc. | MKJ |
| Sep 12, 2007 | K071321 | POCKETCPR Bio-Detek, Inc. | LIX |
| Apr 9, 2004 | K040256 | PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 Bio-Detek, Inc. | MKJ |
| Apr 9, 2004 | K040056 | BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 Bio-Detek, Inc. | MKJ |
| Feb 27, 2004 | K033771 | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR Bio-Detek, Inc. | MKJ |
| Mar 16, 1999 | K984582 | ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX Bio-Detek, Inc. | MKJ |
| Feb 26, 1999 | K990106 | ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES Bio-Detek, Inc. | MKJ |
| Nov 25, 1998 | K981802 | ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 Bio-Detek, Inc. | MKJ |
| Nov 25, 1996 | K964213 | TRACE RITE SOLID GEL ECG ELECTRODES Bio-Detek, Inc. | DRX |
| Aug 14, 1992 | K920352 | BIO-DETEK EEG ELECTRODE Bio-Detek, Inc. | GXZ |
| Jun 2, 1992 | K920264 | BIO-DETEK TRACERITE EEG ELECTRODE Bio-Detek, Inc. | GXY |
| Jul 25, 1991 | K912714 | RT40 RADIO TRANSLUCENT Bio-Detek, Inc. | DRX |
| Jan 7, 1986 | K853038 | DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES Bio-Detek, Inc. | DRX |
| Oct 10, 1985 | K853291 | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 Bio-Detek, Inc. | HAM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2019 | Bio-Detek, Inc. ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) Terminated |
DTE | K960676 |
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single
Part number:
8900-4055-40
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillat Terminated |
MKJ | K943698 |
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires
Part number: 8900-4052
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult Terminated |
MKJ | K943698 |
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single.
Part number: 8900-4013
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disp Terminated |
MKJ | K943698 |
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE)
Part Number: 8900-4012
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable Terminated |
MKJ | K943698 |
| Sep 17, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with
10-ft (3 m) leadwires
Part number: 8900-4052
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These d Terminated |
MKJ | K943698 |
| Sep 17, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes
((singles)
Part number: 8900-4013
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable sing Terminated |
MKJ | K943698 |
| Sep 17, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes
Part number: 8900-4012
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's Terminated |
MKJ | K943698 |
| Sep 2, 2014 | Bio-Detek, Inc. Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monit Terminated |
MKJ | K033771 |
| Feb 13, 2012 | Bio-Detek, Inc. Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE)
Part number: 8900-0401
Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients. Terminated |
K072430 | |
| Sep 20, 2008 | Bio-Detek, Inc. ZOLL OneStep Multi-Function Electrode; Adult Complete
Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, an Terminated |
MLN | K051076 |
| Aug 18, 2004 | Bio-Detek, Inc. Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode
part Number: 8900-2065 Terminated |
DRF | K915159 |