PadPro Model 2603
by Padpro, LLC
510(k) K020288
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020288 | Date27 Feb 2002 | StatusActive |
Recalls
-
- Terminated Z-0459-2015
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 or serious injury.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The PadPro Model 2603 is an Automated External Defibrillator (Non-Wearable) electrode designed for pediatric use. It provides a conductive interface between defibrillators, pacemakers, and pediatric patient skin, enabling defibrillation, cardioversion, pacing, and monitoring functions. The device features a high-tack adhesive polymer gel to ensure uniform current distribution and ease of repositioning.
Supplied as non-sterile and disposable, the PadPro Model 2603 is intended for use in clinical settings such as hospitals or by paramedics. It includes 42-inch leadwires and is classified as a Class III medical device under FDA regulation 870.5310. The device holds FDA 510(k) clearance (K020288) and is intended for single-use applications, with a maximum of 50 shocks, 8 hours of continuous pacing, or 24 hours of patient monitoring.
Other devices from Padpro, LLC
Questions
AI-generated answers, 18 Sep 2026
What is the primary use case for the PadPro Model 2603 in clinical settings?
The PadPro Model 2603 is designed specifically for pediatric patients and serves as a conductive interface between defibrillators, pacemakers, and pediatric skin. It enables critical functions like defibrillation, cardioversion, pacing, and patient monitoring in clinical settings such as hospitals or by paramedics. Its high-tack adhesive polymer gel ensures uniform current distribution and ease of repositioning, making it ideal for emergency pediatric cardiac care.
Is the PadPro Model 2603 reusable, or is it intended for single-use only?
The PadPro Model 2603 is explicitly intended for single-use applications. It is designed to deliver up to 50 shocks, provide 8 hours of continuous pacing, or monitor a patient for 24 hours before it should be replaced. This ensures patient safety and hygiene in clinical environments.
How are the PadPro Model 2603 electrodes supplied, and what should I consider for storage?
The PadPro Model 2603 is supplied as non-sterile and disposable, meaning it is not sterile at the time of packaging. It comes with 42-inch leadwires for connectivity. Since it is non-sterile, storage should be in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its adhesive properties and functionality until use.
What regulatory pathway does the PadPro Model 2603 follow, and what does this mean for buyers?
The PadPro Model 2603 follows the FDA 510(k) clearance pathway, with clearance number K020288, and is classified as a Class III medical device under FDA regulation 870.5310. This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness for its intended use in pediatric defibrillation and monitoring applications. Buyers can trust that the device meets stringent regulatory standards.