Conmed
CONMED Multifunction Electrode Test Component
3manufacturers in China registered for this device type
3catalogue numbers in this listing
13recalls on this code
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | MKJ |
| Device type | Automated External Defibrillators (Non-Wearable) |
| Device class | Class 3 |
| Regulation | 21 CFR 870.5310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K003548 |
| Record published | 2023-10-19 |
| Record revised | 2024-08-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 50 to 90 °F; Storage environment temperature 10 to 32 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHRTG BLOCK | In distribution | |
| QUICK SHORT | In distribution | |
| ZOLL SHORT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X Series | Zoll Medical Corporation | 862 |
| E Series | Zoll Medical Corporation | 571 |
| M Series | Zoll Medical Corporation | 219 |
| R Series | Zoll Medical Corporation | 216 |
| Lifepak® 15 monitor/defibrillator | Physio-Control, Inc. | 188 |
| AED Plus | Zoll Medical Corporation | 124 |
| Lifepak® 12 defibrillator/monitor | Physio-Control, Inc. | 122 |
| Lifepak CR Plus and Lifepak Express defibrillators | Physio-Control, Inc. | 111 |
| M Series Biphasic | Zoll Medical Corporation | 111 |
| PadPro | ConMed Corporation | 96 |
| R&D Batteries, Inc. | R & D Batteries, Inc. | 71 |
| Lifepak® 20 and Lifepak 20e defibrillator/monitors | Physio-Control, Inc. | 59 |
Showing 12 of 312. All products under Automated External Defibrillators (Non-Wearable)
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-02-23 | Class II | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | 18,720 units in total | 2020-09-17 |
| 2018-02-23 | Class II | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | 18,720 units in total | 2020-09-17 |
| 2018-02-23 | Class II | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | 18,720 units in total | 2020-09-17 |
| 2018-02-23 | Class II | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | 18,720 units in total | 2020-09-17 |
| 2018-02-23 | Class II | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | 18,720 units in total | 2020-09-17 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2013-05-03 | Class II | Component design/selection | ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the | Domestic: 49,010; Foreign: 600 | 2015-08-25 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P160008 | 2026-05-07 | HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories | Heartsine Technologies, Ltd |
| P170018 | 2025-11-06 | LIFEPAK® CR2 Automated External Defibrillator | Physio-Control, Inc. |
| P160032 | 2025-07-03 | Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E | Defibtech, LLC |
| P210015 | 2025-01-29 | Avive Automated External Defibrillator (AED) System | Avive Solutions Inc |
| P200005 | 2024-01-09 | TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors | TZ Medical, Inc. |
| P200007 | 2023-06-23 | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads | Graphic Controls D.B.A. Vermed |
| P200004 | 2022-06-16 | ConMed PadPro Multifunction Electrodes | ConMed Corporation |
| P160012 | 2021-07-08 | Infant/Child Reduced Energy Defibrillation Electrodes | Physio-Control, Inc. |
| P160033 | 2021-06-14 | Powerheart G5 AED | Zoll Medical Corporation |
| P190013 | 2021-02-02 | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) | AED Battery Exchange, LLC |
| P180028 | 2020-08-22 | HeartStart FRx Defibrillator | Philips Medical Systems Technologies Ltd |
| P190007 | 2020-08-07 | Cardinal Health Multifunctional Defibrillation Electrode | Cardinalhealth |
| P160022 | 2020-06-11 | X Series and Propaq MD | Zoll Medical Corporation |
| P160015 | 2020-06-05 | AED 3 Defibrillator with Uni-Padz | Zoll Medical Corporation |
| P160028 | 2020-05-11 | Philips HeartStart FR3 Defibrillator | Philips Medical Systems Technologies Ltd |
| P160026 | 2020-02-13 | LIFEPAK Automated External Defibrillators (AEDs) | Physio-Control, Inc. |
| P160034 | 2019-08-20 | Powerheart® G3 Pro AED | Zoll Medical Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.