Defibtech, LLC
FDA Regulatory Profile
Defibtech, LLC appears in FDA public data with 14 recalls — including 1 Class I (most serious) —, 9 510(k) clearances, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1694-2025, Class II) was initiated on March 18, 2025. Its most recent 510(k) clearance was granted on November 9, 2021.
Summary
- Total Recalls
- 14 (1 Class I)
- 510(k) Clearances
- 9
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1694-2025 | Class II | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dua | March 18, 2025 |
| Z-1692-2025 | Class II | Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual | March 18, 2025 |
| Z-1693-2025 | Class II | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) | March 18, 2025 |
| Z-1690-2025 | Class II | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 | March 18, 2025 |
| Z-1691-2025 | Class II | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dua | March 18, 2025 |
| Z-0503-2025 | Class II | Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline | October 14, 2024 |
| Z-0505-2025 | Class II | Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, life | October 14, 2024 |
| Z-0504-2025 | Class II | Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline | October 14, 2024 |
| Z-0502-2025 | Class II | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DD | October 14, 2024 |
| Z-2543-2024 | Class I | RMU-2000 Automated Chest Compression Device | July 12, 2024 |
| Z-1312-2023 | Class II | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardi | February 14, 2023 |
| Z-2393-2020 | Class II | DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) | April 27, 2020 |
| Z-2392-2020 | Class II | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN | April 27, 2020 |
| Z-2394-2020 | Class II | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450 | April 27, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211289 | RMU-2000 Automated Chest Compression System | November 9, 2021 |
| K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | October 27, 2014 |
| K131525 | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | April 24, 2014 |
| K113787 | DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | January 4, 2013 |
| K121853 | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | December 13, 2012 |
| K081259 | DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | June 15, 2009 |
| K033896 | DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P | June 16, 2004 |
| K033144 | DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES | November 13, 2003 |
| K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATT | June 19, 2002 |