510(k) Report

FDA applicant

Defibtech, LLC

Guilford, CT10 decisions2002–202115 recalls

FDA records 10 decisions for Defibtech, LLC (Guilford, CT) from 2002 to 2021: 9 510(k) clearances and 1 original PMA approval. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and DRM (Compressor, Cardiac, External). Its devices cite 14 predicates, 6 of them its own earlier devices. 15 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Defibtech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2009: 12012: 12013: 12014: 22018: 12021: 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

5in 2025

2007: 12010: 32011: 12024: 5, 1 Class I2025: 5
2007high 5 (2024) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Defibtech, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Defibtech, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)8decisions
  • DRMCompressor, Cardiac, External2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033896Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200PDefibtech, LLC · 20043cite it
  • K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 20093cite it
  • K013896Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack…Defibtech, LLC · 20023cite it

What has FDA decided for it lately?

  • K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 20211 Class I recall
  • P160032Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR…Defibtech, LLC · 20189 recalls
  • K141809Rmu-1000 Automated Chest Compression SystemDefibtech, LLC · 2014
  • K131525Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014
  • K113787Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC · 2013
  • K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2012
  • K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009
  • K033896Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200PDefibtech, LLC · 20041 recall

All 10 as Defibtech, LLC →

What has been recalled?

15 recalls linked to its devices; the latest:

  • P160032Automated External Defibrillators, Model DDU-2200, IItem numbers…Mar 18, 2025Class II
  • P160032Automated External Defibrillators, Model DDU-2200, IItem numbers…Mar 18, 2025Class II
  • P160032Automated External Defibrillators, Model DDU-2300. Item numbers…Mar 18, 2025Class II
  • P160032Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German…Mar 18, 2025Class II
  • P160032Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers…Mar 18, 2025Class II
  • P160032Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and…Oct 14, 2024Class II