Defibtech LLC
Guilford, CT, US
DEFIBTECH LLC appears in FDA device records in Guilford, CT. FDA records list 9 510(k) clearances between and , 17 PMA records and 2 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Defibtech LLC between 2002 and 2021. The busiest year on record is 2014, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211289 | RMU-2000 Automated Chest Compression System | DRM | Substantially Equivalent | |
| K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | DRM | Substantially Equivalent | |
| K131525 | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | Substantially Equivalent | |
| K113787 | DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | Substantially Equivalent | |
| K121853 | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | Substantially Equivalent | |
| K081259 | DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | Substantially Equivalent | |
| K033896 | DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P | MKJ | Substantially Equivalent | |
| K033144 | DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES | MKJ | Substantially Equivalent | |
| K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA | MKJ | Substantially Equivalent - Subject to Tracking Reg. |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3026976873 | 3026976873 | DEFIBTECH LLC | 21, N Branford, CT 06471 US | 2026 | |
| 3003521780 | 3003521780 | DEFIBTECH, LLC | 741 BOSTON POST ROAD,SUITE 201, GUILFORD, CT 06437 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1694-2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language) | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian). | Class II | Open, Classified | |
| Z-1693-2025 | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian). | Class II | Open, Classified | |
| Z-1692-2025 | 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), DCF-E2310G3/1(French/German dual language), DCF-E2310IT (Italian language) | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian). | Class II | Open, Classified | |
| Z-1691-2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language) | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian). | Class II | Open, Classified | |
| Z-1690-2025 | 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) | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian). | Class II | Open, Classified | |
| Z-0505-2025 | 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 cardiac arrest (SCA.) | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient | Class II | Open, Classified | |
| Z-0504-2025 | 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 arrest (SCA.) | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient | Class II | Open, Classified | |
| Z-0503-2025 | 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.) | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient | Class II | Open, Classified | |
| Z-0502-2025 | 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) | Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient. | Class II | Open, Classified | |
| Z-2543-2024 | RMU-2000 Automated Chest Compression Device | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death. | Class I | Open, Classified | |
| Z-1312-2023 | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest | A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy. | Class II | Open, Classified | |
| Z-2394-2020 | 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, 00815098020317 Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally. | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range. | Class II | Terminated | |
| Z-2393-2020 | 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 unresponsive, not breathing or not breathing normally. | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range. | Class II | Terminated | |
| Z-2392-2020 | 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 DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally. | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range. | Class II | Terminated | |
| Z-2064-2011 | 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 sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED. | Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process | Terminated | ||
| Z-0077-2011 | 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. | Data cards may include an incorrect format which may cause the AED to not function correctly. | Terminated | ||
| Z-1782-2010 | 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 does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing. | The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy | Terminated | ||
| Z-1781-2010 | 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 AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing. | The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy | Terminated | ||
| Z-0581-2007 | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier) | Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient. | Terminated | ||
| Z-0580-2007 | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier) | Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain