Panels › Cardiovascular › Product code MKJ · Class 3
Automated External Defibrillators (Non-Wearable)
Regulation 870.5310
0510(k)s in 12 months (228 all time)
4recalls in 12 months (338 all time)
257recalls that name a 510(k)
Top companies in MKJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | HeartSine Technologies Ltd HeartSine samaritan PAD (Public Access Defibrillator);
HeartSine SAM 350P
350P US Device, US English - 2 Min CPR
UDI-DI codes: 0506016712067
350P US Device, US English (American Airlines) - 2 Min Open, Classified |
MKJ | None listed |
| Sep 4, 2026 | HeartSine Technologies Ltd HeartSine SAM 350P
350P US Device, US English - 2 Min CPR
UDI-DI codes:
0506016712067
350P US Device, US English (American Airlines) - 2 Min CPR
UDI-DI code:
0506016712207
350P US Device, US English Open, Classified |
MKJ | None listed |
| May 4, 2026 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 9 Open, Classified |
MKJ | None listed |
| Mar 10, 2026 | Physio-Control, Inc. PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes
Catalog Numbers: 11101-000016
UDI-DI code: 00721902629013
Catalog Number: 11101-000017
UDI-DI code: 00721902682483
Infant/Child Re Open, Classified |
MKJ | None listed |
| Oct 23, 2025 | HeartSine Technologies Ltd HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J Open, Classified |
MKJ | None listed |
| Sep 2, 2025 | Physio-Control, Inc. LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code:
CR2-2-001451 99512-001434 883873785911
LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiop Open, Classified |
MKJ | None listed |
| Sep 2, 2025 | Physio-Control, Inc. LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code:
320371500023 / 99425-000025 / 885074698953
320371500229 / 99425-000025 / 885074698953
331706400001 / 99425-000025 / 885074698953
LIFEPAK 1000: The Open, Classified |
MKJ | None listed |
| Sep 2, 2025 | Physio-Control, Inc. LIFEPAK 15 Part / Catalog Numbers / UDI-DI code:
V15-7-000022 / 99577-001957 / 883873871690
V15-2-000051 / 99577-000046 / 883873988022
V15-2-000099 / 99577-000093 / 883873979020
V15-2-001603 / 99577- Open, Classified |
MKJ | None listed |
| Jul 25, 2025 | HeartSine Technologies Ltd HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P
The HeartSine samaritan PAD (Public Access Defibrillator) Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language) Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1(German/English dual language), DCF-E2310E3/1(German/French dual language), DCF-E2310F3/1 (French/English dual language), Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language) Open, Classified |
MKJ | None listed |
| Apr 29, 2025 | Defibtech, LLC 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) Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: G5S-80A;
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treat Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: G5S-80C;
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treat Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C;
Software Version: NA
Product Description: The Powerheart G5 automated externa Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO.
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO.
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO.
Software Version: NA
Product Descr Open, Classified |
MKJ | None listed |
| Feb 25, 2025 | Physio-Control, Inc. LIFEPAK 20e REF 99507-000001
The AED mode is to be used only on patients in cardiopulmonary arrest. Open, Classified |
MKJ | None listed |
| Feb 19, 2025 | Physio-Control, Inc. LIFEPAK 15 V4/Masimo Rainbow Sensors:
Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515
Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sensor REF 11996-000519 Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series
-Indicated for use on victims of sudden ca Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and
Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.) Open, Classified |
MKJ | None listed |
| Nov 25, 2024 | Defibtech, LLC 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) Open, Classified |
MKJ | None listed |
| Oct 25, 2024 | Physio-Control, Inc. LIFEPAK 15 (LP15) Model/Catalog Numbers:
o 97577-000101
o 99577-000046
o 99577-000055
o 99577-000061
o 99577-000076
o 99577-001250
o 99577-001255
o 99577-001256
o 99577-001368
o 99577-001955
o 99577-0 Open, Classified |
MKJ | None listed |
| Jul 10, 2024 | Zoll Medical Corporation ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, tha Open, Classified |
MKJ | None listed |
| May 14, 2024 | HeartSine Technologies Ltd HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P Open, Classified |
MKJ | None listed |
| Feb 15, 2024 | HeartSine Technologies Ltd HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-0 Open, Classified |
MKJ | None listed |
| Dec 15, 2023 | Physio-Control, Inc. AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 Open, Classified |
MKJ | None listed |
| Jul 13, 2023 | HeartSine Technologies Ltd HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P Open, Classified |
MKJ | None listed |
| Mar 30, 2023 | Defibtech, LLC DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest Open, Classified |
MKJ | None listed |
| Mar 3, 2023 | HeartSine Technologies Ltd Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator,
SAM 360P fully automatic defibrillator,
SAM 500P semi-automatic defibrillator with CPR Advisor Open, Classified |
MKJ | None listed |
| Apr 6, 2022 | Philips North America LLC Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS Open, Classified |
MKJ | None listed |
| Apr 6, 2022 | Philips North America LLC Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS Open, Classified |
MKJ | None listed |
| Jan 13, 2022 | Physio-Control, Inc. HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak Terminated |
MKJ | None listed |
| Oct 8, 2021 | Philips North America LLC Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A Open, Classified |
MKJ | None listed |
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