Defibtech, LLC

FDA Regulatory Profile

Summary

Total Recalls
14 (1 Class I)
510(k) Clearances
9
Inspections
10
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1690-2025Class IISemi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 March 18, 2025
Z-1692-2025Class IIAutomated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual March 18, 2025
Z-1691-2025Class IIAutomated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English duaMarch 18, 2025
Z-1693-2025Class IIAutomated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)March 18, 2025
Z-1694-2025Class IIAutomated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English duaMarch 18, 2025
Z-0504-2025Class IIDefibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifelineOctober 14, 2024
Z-0502-2025Class IIDefibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDOctober 14, 2024
Z-0503-2025Class IIDefibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline October 14, 2024
Z-0505-2025Class IIDefibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeOctober 14, 2024
Z-2543-2024Class IRMU-2000 Automated Chest Compression DeviceJuly 12, 2024
Z-1312-2023Class IIDDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiFebruary 14, 2023
Z-2392-2020Class IIDDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN April 27, 2020
Z-2394-2020Class IIDDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450April 27, 2020
Z-2393-2020Class IIDDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED)April 27, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K211289RMU-2000 Automated Chest Compression SystemNovember 9, 2021
K141809RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEMOctober 27, 2014
K131525SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESApril 24, 2014
K113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESJanuary 4, 2013
K121853DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDecember 13, 2012
K081259DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESJune 15, 2009
K033896DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200PJune 16, 2004
K033144DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIESNovember 13, 2003
K013896SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTJune 19, 2002