Identifiers
- 510(k) Number
- K142709 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 Samaritan PAD 450P is a semi-automatic automated external defibrillator (AED) designed to deliver lifesaving electrical shocks for victims of sudden cardiac arrest. It provides voice and visual guidance to rescuers, including real-time feedback on CPR compression rate and quality, to optimize resuscitation efforts.
This device is intended for single-use and is supplied as a portable, non-reusable unit. It is classified as a Class III medical device under FDA regulations (870.5310) and has received FDA 510(k) clearance (K142709). The Samaritan PAD 450P is available with optional Wi-Fi connectivity for remote monitoring and data transmission, and it features an IP56 rating for protection against dust and water ingress. Storage and handling follow standard AED protocols to ensure functionality and sterility.
Frequently asked questions
Is the Samaritan PAD 450P designed for reuse or is it intended for single-use only?
The Samaritan PAD 450P is explicitly designed for single-use only. This is a key feature of the device, as it ensures sterility and reliability for emergency cardiac arrest situations, preventing any risk of cross-contamination or degradation from repeated use.
What kind of environmental protection does the Samaritan PAD 450P have, and how does this affect its usability?
The Samaritan PAD 450P has an IP56 rating, meaning it is protected against dust ingress and can withstand temporary immersion in water (e.g., rain or accidental splashes). This makes it highly durable for outdoor or public-use environments where exposure to elements is likely, ensuring reliable operation in critical situations.
Can the Samaritan PAD 450P be connected to a network for remote monitoring, and if so, how does this feature benefit users?
Yes, the Samaritan PAD 450P is available with optional Wi-Fi connectivity, allowing for remote monitoring and data transmission. This feature enables healthcare providers or emergency responders to track device usage, review resuscitation events, and ensure proper maintenance—improving response coordination and post-event analysis.
How is the device stored and handled to maintain its functionality and sterility?
The Samaritan PAD 450P follows standard AED storage and handling protocols to preserve functionality and sterility. Since it is single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging and maintenance of the unit ensure readiness for emergency use when needed.
What regulatory pathway was followed for FDA clearance of the Samaritan PAD 450P, and what does this mean for its use?
The Samaritan PAD 450P received FDA 510(k) clearance (K142709) through a traditional review pathway, determined to be *substantially equivalent* to a legally marketed predicate device. This means it meets FDA safety and performance standards for automated external defibrillators and is authorized for use in emergency cardiac arrest scenarios as intended by its design.
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: HeartSine Connected samaritan PAD 450P - HeartSine, HeartSine Connected samaritan PAD 450P - HeartSine, Products - HeartSine, HeartSine Samaritan PAD 450P - secure.heartsafeusa.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142709 | Class III | Active |
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Manufacturer
- Manufacturer
- Heartsine Technologies, Inc.
Sources (1)
- FDA 510(k) K142709 24 fields · synced Sep 18, 2026