# Bio-Detek, Inc.

- Location (FDA's records): Pawtucket, RI
- FDA decisions: 17 (1985–2015): 17 510(k) clearances
- Product codes: MKJ (10), DRX (3), LIX (1), HAM (1), GXY (1), GXZ (1)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 11 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ZOLL Medical Corporation: 3 (https://510kreport.com/company/zoll-medical)
- Zmi Corp.: 1 (https://510kreport.com/company/zmi)
- Zoll Medical Corporation, World Wide Headquarters: 1 (https://510kreport.com/company/zoll-medical-world-wide-headquarters)
- Hewlett-Packard Co.: 1 (https://510kreport.com/company/hewlett-packard)

## Firms that cite its devices most
- ZOLL Medical Corporation: 3 (https://510kreport.com/company/zoll-medical)
- Rapid Response Solutions, LLC: 1 (https://510kreport.com/company/rapid-response-solutions)
- Laerdal Medical A/S: 1 (https://510kreport.com/company/laerdal-medical-a-s)
- Paladin Medical, Inc.: 1 (https://510kreport.com/company/paladin-medical)
- Avantech, Inc.: 1 (https://510kreport.com/company/avantech)
- Physio-Control Corp.: 1 (https://510kreport.com/company/physio-control)
- Team Innovations, Inc.: 1 (https://510kreport.com/company/team-innovations)

## Its most-cited devices
- K071321: Pocketcpr (2007), cited by 5
- K964213: Trace Rite Solid Gel Ecg Electrodes (1996), cited by 2
- K981802: Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003 (1998), cited by 1
- K133441: Onestep CPR II Multi-Function Electrode (2014), cited by 1
- K100565: Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325 (2010), cited by 1
- K853291: GP-100 Adult Electrosurgical Ground Pad/200 & 300 (1985), cited by 1

## Recent decisions
- K150055: OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
- K150198: CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
- K133441: Onestep CPR II Multi-Function Electrode (Oct 10, 2014)
- K100565: Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325 (Nov 16, 2010)
- K071321: Pocketcpr (Sep 12, 2007)
- K040256: Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005 (Apr 9, 2004)
- K040056: Bio-Detek Electrode Adapter, Model R2001-90 (Apr 9, 2004)
- K033771: Bio-Detek Modified Adult Multi-Function Electrode with Connector (Feb 27, 2004)

Source page: https://510kreport.com/company/bio-detek