HeartStart SmartPads III
FDA 510(k)EUDAMEDClass III (US FDA 510(k))
Identifiers
- 510(k) Number
- K072812 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HeartStart SmartPads III are automated external defibrillator (AED) adhesive electrode pads designed for use with Philips HeartStart defibrillators. These pads deliver synchronized electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest by analyzing heart rhythm and delivering appropriate therapy when needed.
The SmartPads III are intended for single-use and are supplied sterile in sealed packaging. They are classified as Class III medical devices under FDA regulations and have received FDA 510(k) clearance and MDR authorization. Each pad is pre-connected to the defibrillator via a cable and must be stored in a dry, clean environment away from direct sunlight until use.
Frequently asked questions
Are the Philips HeartStart SmartPads III reusable or designed for single-use only?
The Philips HeartStart SmartPads III are explicitly designed for single-use only. This is confirmed by the manufacturer’s description, which states they are supplied sterile in sealed packaging and should not be reused after application.
How should the Philips HeartStart SmartPads III be stored before use?
The pads must be stored in a dry, clean environment away from direct sunlight until use. The manufacturer’s instructions emphasize this to maintain their integrity and sterility, as they are supplied sterile in sealed packaging.
What defibrillator models are compatible with the Philips HeartStart SmartPads III?
These pads are specifically designed for use with Philips HeartStart defibrillators. The description clarifies they are pre-connected via cable, so compatibility is limited to the Philips HeartStart series only.
Are there different sizes or models of Philips HeartStart SmartPads III available?
The provided data does not specify multiple sizes or models beyond the standard SmartPads III configuration. The description and regulatory details focus on a single product line, implying a unified design for adult use (common for AED pads).
What regulatory pathways have the Philips HeartStart SmartPads III followed?
The device has received FDA 510(k) clearance and MDR authorization, confirming compliance with both U.S. and EU regulatory requirements. The clearance type is traditional, and it falls under the Cardiovascular advisory committee, reflecting its classification as a Class III device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Global home | Philips
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K072812 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (2)
- FDA 510(k) K072812 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026