MKJFDA Class 3 · 21 CFR 870.5310
Automated External Defibrillators (Non-Wearable)
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
492
Manufacturers
26
Flagged signals
16
Adverse-event reports
220,272
Code matrix
| FDA product code | MKJ |
| Device class | Class 3 |
| Regulation | 21 CFR 870.5310 |
| GMDN | 35260 |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2014 | 3 | 46.4 | 92 |
| Other | 2010 | 79 | 38.7 | 2,860 |
| Death | 2011 | 12 | 10.3 | 93 |
| Death | 2017 | 3 | 9.5 | 15 |
| Death | 2010 | 69 | 5.8 | 269 |
| Death | 2026 | 4 | 4.9 | 9 |
| Death | 2011 | 58 | 4.8 | 174 |
| Other | 2011 | 9 | 4.4 | 20 |
| Death | 2014 | 5 | 4.3 | 10 |
| Other | 2012 | 8 | 3.9 | 15 |
| Death | 2010 | 4 | 3.4 | 5 |
| Death | 2013 | 4 | 3.4 | 5 |
| Other | 2009 | 6 | 2.9 | 6 |
| Death | 2011 | 18 | 2.6 | 17 |
| Injury | 2018 | 45 | 2.1 | 40 |
| Death | 2009 | 25 | 2.1 | 13 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 220,272 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| PHYSIO-CONTROL, INC. | 103 | 2026 | — |
| Zoll Medical Corporation | 101 | 2025 | — |
| Philips Medical Systems | 35 | 2026 | — |
| Heartsine Technologies, Ltd. | 29 | 2026 | — |
| Defibtech, LLC | 21 | 2025 | — |
| Physio-Control Corp. | 11 | 1999 | — |
| Bio-Detek, Inc. | 10 | 2015 | — |
| Philips Medical Systems, Inc. | 8 | 2025 | — |
| Cardiac Science Corporation | 6 | 2015 | — |
| Graphic Controls Corp. | 6 | 1998 | — |
| Hewlett-Packard Co. | 6 | 2000 | — |
| Leonhard Lang GmbH | 5 | 2014 | — |
| Avive Solutions, Inc. | 5 | 2025 | — |
| Amco International Manufacturing & Design, Inc. | 4 | 2009 | — |
| AGILENT TECHNOLOGIES, INC. | 4 | 2001 | — |
| Marquette Electronics, Inc. | 4 | 1995 | — |
| AED BATTERY EXCHANGE, LLC | 3 | 2025 | — |
| Graphic Controls D.B.A. Vermed | 3 | 2025 | — |
| Conmed Corporation | 2 | 2022 | — |
| Medical Devices, Inc. | 1 | 2001 | — |
| Philips Medical Systems North America, Inc. | 1 | 2006 | — |
| R & D Batteries, Inc. | 1 | 2014 | — |
| WELCH ALLYN, INC. | 1 | 2004 | — |
| Cardinalhealth | 1 | 2020 | — |
| CU Medical Systems, Inc. | 1 | 2008 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
LIFEPAK 35 monitor/defibrillator · Physio-Control, Inc.PMA · 2026-03-05
LIFEPAK® 35 monitor/defibrillator · Physio-Control, Inc.PMA · 2026-02-23
HeartStart FRx Defibrillator · Philips Medical SystemsPMA · 2026-02-02
HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories · Heartsine Technologies, Ltd.PMA · 2026-01-08
OneStep CPR Complete Electrode · ZOLL Medical CorporationPMA · 2025-12-30
samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories · Heartsine Technologies, Ltd.PMA · 2025-12-22
HeartSync Multifunction Disposable Single-Use Defibrillator Pads · Graphic Controls D.B.A. VermedPMA · 2025-12-19
AED 3 · ZOLL Medical CorporationPMA · 2025-12-18
X Series®; Propaq MD®; AED 3 BLS; Zenix Professional Defibrillators · ZOLL Medical CorporationPMA · 2025-12-18
ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci · ZOLL Medical CorporationPMA · 2025-12-09
LIFEPAK® 35 Defibrillator/monitor · Physio-Control, Inc.PMA · 2025-12-04
LIFEPAK® 35 monitor/defibrillator · Physio-Control, Inc.PMA · 2025-11-21
HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads · Graphic Controls D.B.A. VermedPMA · 2025-11-12
LIFEPAK® CR2 Automated External Defibrillator · Physio-Control, Inc.PMA · 2025-11-06
DBP-1400-ABE and DBP-2003- ABE · Aed Battery Exchange, LLCPMA · 2025-10-28
LIFEPAK 1000 defibrillator · Physio-Control, Inc.PMA · 2025-10-14
HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) · Heartsine Technologies, Ltd.PMA · 2025-09-29
LIFEPACK® CR2 Automated External Defibrillator (AED) · Physio-Control, Inc.PMA · 2025-09-29
ZOLL Zenix® Monitor/Defibrillator · ZOLL Medical CorporationPMA · 2025-09-29
CPR-D-padz Electrode · ZOLL Medical CorporationPMA · 2025-09-22
CPR Uni-padz Electrode · ZOLL Medical CorporationPMA · 2025-09-22
HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories · Heartsine Technologies, Ltd.PMA · 2025-09-17
HeartStart FRx Defibrillator and HeartStart SMART Pads II · Philips Medical SystemsPMA · 2025-09-05
HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories · Heartsine Technologies, Ltd.PMA · 2025-09-02
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS · ZOLL Medical CorporationPMA · 2025-08-28
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.