Company ยท US
Defibtech, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2021. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2021 | K211289 | RMU-2000 Automated Chest Compression System Defibtech, LLC | DRM |
| Oct 27, 2014 | K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM Defibtech, LLC | DRM |
| Apr 24, 2014 | K131525 | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Jan 4, 2013 | K113787 | DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Dec 13, 2012 | K121853 | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Jun 15, 2009 | K081259 | DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Jun 16, 2004 | K033896 | DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P Defibtech, LLC | MKJ |
| Nov 13, 2003 | K033144 | DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES Defibtech, LLC | MKJ |
| Jun 19, 2002 | K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA Defibtech, LLC | MKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language) Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1(German/English dual language), DCF-E2310E3/1(German/French dual language), DCF-E2310F3/1 (French/English dual language), Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language) Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language) Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series
-Indicated for use on victims of sudden ca Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and
Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.) Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline
Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA) Open, Classified |
MKJ | None listed |
| Aug 14, 2024 | Defibtech, LLC RMU-2000 Automated Chest Compression Device Open, Classified |
DRM | K211289 |
| Mar 30, 2023 | Defibtech, LLC DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest Open, Classified |
MKJ | None listed |
| Apr 27, 2020 | Defibtech, LLC DDU-2450 Lifeline ECG
Model Numbers DDU-A2450EN
DDU-E2450DE
DDU-E2450EN
DDU-E2450FR
DDU-E2450TH
Cat. No. DCF-A2460EN
DCF-A2463EN
DCF-E2460DE
DCF-E2460EN
DCF-E2460FR
DCF-E2460TH
UDI 00815098020287,
Terminated |
MKJ | None listed |
| Apr 27, 2020 | Defibtech, LLC DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unrespon Terminated |
MKJ | None listed |
| Apr 27, 2020 | Defibtech, LLC DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN
Catalog Numbers CCD-A1006RX
CCD-A1013EN
CCD-A1015EN
DCF-A2310EN
DCF-A2310RX
DCF-A2313EN
DCF-C2310CA
DC Terminated |
MKJ | None listed |
| May 16, 2011 | Defibtech, LLC Defibtech Lifeline AED and ReviveR AED,
Model: DDU-100 Series AEDs
Software version 2.004 or earlier
The product under correction is the DDU-100 AED. The AED is indicated for use on victims of su Terminated |
MKJ | K013896 K033896 |
| Oct 18, 2010 | Defibtech, LLC DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED).
The DDC-6-AA data card is an accessory to the AED and does not have its own intended use. Terminated |
MKJ | K013896 |
| Jun 10, 2010 | Defibtech LLC ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483.
The DBP-2800 battery pack is an accessory to the AED and do Terminated |
MKJ | K013896 |
| Jun 10, 2010 | Defibtech LLC Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483.
The DBP-2800 battery pack is an accessory to the AE Terminated |
MKJ | K013896 |
| Mar 8, 2007 | Defibtech, LLC Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier) Terminated |
MKJ | None listed |
| Mar 8, 2007 | Defibtech, LLC Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier) Terminated |
MKJ | K013896 |