Defibtech, LLC: FDA clearances and approvals
Defibtech, LLC has 9 FDA 510(k) clearances (first 2002, latest 2021), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time: 195 days. openFDA lists 20 product recalls by a recalling firm named Defibtech, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 171 |
| 2013 | 1 | 379 |
| 2014 | 2 | 222 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 195 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Defibtech, LLC's cleared 510(k)s took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 195 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 8 | 7 |
| DRM | Compressor, Cardiac, External | 2 | 2 |
Review panels
- Cardiovascular (10)
Most recent Defibtech, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211289 | RMU-2000 Automated Chest Compression System | DRM | 2021-11-09 | 195 |
| K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | DRM | 2014-10-27 | 112 |
| K131525 | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | 2014-04-24 | 331 |
| K113787 | DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | 2013-01-04 | 379 |
| K121853 | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | 2012-12-13 | 171 |
| K081259 | DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | MKJ | 2009-06-15 | 409 |
| K033896 | DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P | MKJ | 2004-06-16 | 183 |
| K033144 | DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES | MKJ | 2003-11-13 | 44 |
| K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA | MKJ | 2002-06-19 | 208 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160032 | PMA | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- | 2018-02-01 |
Recalls
20 product recalls in 10 recall events; 11 initiated in the last five years. Most recent: 2025-03-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Defibtech, LLC have?
Defibtech, LLC has 9 FDA 510(k) clearances (first 2002, latest 2021), plus 1 PMA decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Defibtech, LLC's 510(k)s?
The median time from FDA receipt to decision across Defibtech, LLC's cleared 510(k)s is 195 days.
What devices does Defibtech, LLC make?
Its most frequent FDA product codes are MKJ (Automated External Defibrillators (Non-Wearable), 8); DRM (Compressor, Cardiac, External, 2).
Has Defibtech, LLC had device recalls?
openFDA lists 20 product recalls in 10 recall events by a recalling firm whose name matches Defibtech, LLC; the most recent began 2025-03-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Defibtech, LLC clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Defibtech, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.