Cardio Clear
Cardio Clear electrodes provide the electrical connection between an adult patient’s skin and a compatible defibrillator or external cardiac pacemaker. They are used for defibrillation,…
Cardio Clear electrodes provide the electrical connection between an adult patient’s skin and a compatible defibrillator or external cardiac pacemaker. They are used for defibrillation, cardioversion, external pacing, and ECG monitoring.
The self-adhesive pads use conductive hydrogel at the skin interface and are radiotransparent. They are packaged in pairs. The listed version uses a Zoll connector, which must match the connected instrument.
Listed Item
RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out, Short Cord
Use Conditions
The electrodes are supplied nonsterile for disposable use on a single patient. They are intended for compatible monophasic or biphasic equipment with a maximum defibrillator output of 360 joules.
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 | Cardio Medical Products, Inc., United States |
|---|---|
| FDA product code | LDD |
| Device type | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5300 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K103159 |
| Record published | 2015-07-28 |
| Record revised | 2025-08-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -20 to 40 °C; Storage environment temperature -4 to 104 °F |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| O101 | In distribution | |
| LOCP503 | In distribution | |
| Z100 | In distribution | |
| TZ200 | In distribution | |
| PA302 | In distribution | |
| P103 | In distribution | |
| Z400 | In distribution | |
| A402 | In distribution | |
| TH204 | In distribution | |
| A102 | In distribution | |
| LOCO501 | In distribution | |
| O401 | In distribution | |
| PH304 | In distribution | |
| LZ100 | In distribution | |
| LOCH504 | In distribution | |
| LZ100-S | In distribution | |
| LTH204 | In distribution | |
| P403 | In distribution | |
| H404 | In distribution | |
| TO201 | In distribution | |
| LTZ200 | In distribution | |
| LTO201 | In distribution | |
| LOCZ500 | In distribution | |
| O101-S | In distribution | |
| LTP203 | In distribution | |
| TA202 | In distribution | |
| TP203 | In distribution | |
| PZ300 | In distribution | |
| PO301 | In distribution | |
| PP303 | In distribution | |
| LOCA502 | In distribution | |
| H104 | In distribution | |
| LTA202 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unipower | Unipower Corp. | 623 |
| Internal Handle | Zoll Medical Corporation | 89 |
| Vermed | Nissha Medical Technologies Limited | 47 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Fiab SPA | 20 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Physio-Control, Inc. | 20 |
| R2 | ConMed Corporation | 17 |
| HeartStart | Philips Medical Systems Hsg | 9 |
| Anybattery | Anybattery, Inc | 6 |
| Tempus LS-Manual | Remote Diagnostic Technologies Ltd. | 6 |
| Vermed Defib Pads | Graphic Controls Acquisition Corporation | 5 |
| HeartStart | Philips Electronics North America Corporation | 4 |
| Heartsync by Vermed | Graphic Controls Acquisition Corporation | 4 |
Showing 12 of 29. All products under Dc-Defibrillator, Low-Energy, (Including Paddles)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103651 | 2011-10-04 |
| K103334 | 2011-01-18 |
| K103159 | 2011-01-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cardio Medical Products, Inc. | 510(k) number | 2013-04-26 | Class II | Process control | Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101. | 657 units | 2016-08-15 |
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.