# Defibtech, LLC

- Location (FDA's records): Guilford, CT
- FDA decisions: 10 (2002–2021): 9 510(k) clearances and 1 original PMA approval
- Product codes: MKJ (8), DRM (2)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 15 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jolife AB: 2 (https://510kreport.com/company/jolife)
- Heartstream, Inc.: 2 (https://510kreport.com/company/heartstream)
- Agilent Technologies, Inc.: 1 (https://510kreport.com/company/agilent-technologies)
- Katecho, Inc.: 1 (https://510kreport.com/company/katecho)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Hewlett-Packard Co.: 1 (https://510kreport.com/company/hewlett-packard)

## Firms that cite its devices most
- Aed Battery Exchange, LLC: 2 (https://510kreport.com/company/aed-battery-exchange)
- Cu Medical Systems, Inc.: 1 (https://510kreport.com/company/cu-medical-systems)

## Its most-cited devices
- K033896: Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P (2004), cited by 3
- K081259: Ddu-2300 Semiautomatic External Defibrillator and Accessories (2009), cited by 3
- K013896: Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA (2002), cited by 3

## Recent decisions
- K211289: RMU-2000 Automated Chest Compression System (Nov 9, 2021)
- P160032: Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- (Feb 1, 2018)
- K141809: Rmu-1000 Automated Chest Compression System (Oct 27, 2014)
- K131525: Semiautomatic External Defibrillator and Accessories (Apr 24, 2014)
- K113787: Ddu-120 Fully Automatic External Defibrillator and Accessories (Jan 4, 2013)
- K121853: Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories (Dec 13, 2012)
- K081259: Ddu-2300 Semiautomatic External Defibrillator and Accessories (Jun 15, 2009)
- K033896: Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P (Jun 16, 2004)

Source page: https://510kreport.com/company/defibtech