Data / Medical devices / United States / Defibtech, LLC
Defibtech, LLC: FDA-registered device maker in Guilford, CT, United States, 2 510(k) clearances and 1 PMA approval
Defibtech, LLC is registered with the FDA (registration 3003521780) in Guilford, CT, United States. It lists 2 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated November 9, 2021. 9 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3003521780
- Address
- 741 Boston Post Road,suite 201, Guilford, CT, United States, 06437
- Owner or operator
- DEFIBTECH, LLC (9048526)
- Roles
- Specification developer
- First device listed
- October 30, 2014
- Registered through
- 2027
- Brand names listed
- DBP-1400 5-year non-rechargeable battery pack, DBP-2003 4-year non-rechargeable battery pack, DBP-2013 4-year non-rechargeable TSO battery, DBP-2800 7-year non-rechargeable battery pack, DDP-100 Adult Defibrillation Pads, DDP-2001 Adult Defibrillation Pads, DDP-2002 Pediatric Defibrillation Pads, DDP-200P Pediatric Defibrillation Pads and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Specification developer | accessdata.fda.gov |
| Compressor, Cardiac, External | DRM | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2021 | K211289 | RMU-2000 Automated Chest Compression System | DRM | Substantially Equivalent | Defibtech, LLC | accessdata.fda.gov |
| October 27, 2014 | K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | DRM | Substantially Equivalent | Defibtech, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 1, 2018 | P160032 | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- | MKJ | 17 | August 25, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 18, 2025 | 96653 | Class II | Ongoing | 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). | accessdata.fda.gov |
| March 18, 2025 | 96618 | Class II | Ongoing | 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). | accessdata.fda.gov |
| October 14, 2024 | 95594 | Class II | Ongoing | 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 | accessdata.fda.gov |
| July 12, 2024 | 94960 | Class I | Ongoing | 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. | accessdata.fda.gov |
| February 14, 2023 | 91799 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 27, 2020 | 85702 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| April 1, 2011 | 58160 | Not yet classified | Terminated | 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) | Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process | accessdata.fda.gov |
| August 27, 2010 | 56729 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| February 17, 2007 | 37394 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated External Defibrillators (Non-Wearable)
- All makers of Compressor, Cardiac, External
Updated August 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.