Data / Medical devices / United States / Defibtech Branford
Defibtech Branford: FDA-registered device maker in Branford, CT, United States, 2 510(k) clearances and 1 PMA approval
Defibtech Branford is registered with the FDA (registration 3012972516) in Branford, CT, United States. It lists 4 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated November 9, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012972516
- Address
- 14 Commercial St, Branford, CT, United States, 06405
- Owner or operator
- DEFIBTECH, LLC (9048526)
- Roles
- Contract manufacturer, Manufacturer
- 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 | Manufacturer | accessdata.fda.gov |
| Compressor, Cardiac, External | DRM | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Peripheral, Electric | KOI | 2 | Contract manufacturer | 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 |
Compare with other makers
- All makers of Compressor, Cardiac, External
- All makers of Stimulator, Nerve, Peripheral, Electric
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Automated External Defibrillators (Non-Wearable)
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.