Heartstream Attenuated Defibrillation Pads Model M3870A
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K003819 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 Heartstream Attenuated Defibrillation Pads Model M3870A are a type of automated external defibrillator (non-wearable) electrode system designed to deliver defibrillation shocks to the chest wall. These pads are intended for use with defibrillators to restore normal heart rhythm during cardiac arrest by delivering controlled electrical energy to the heart.
The pads are supplied as a single-use, non-sterile device and are intended for use in emergency cardiovascular settings. They are compatible with specific defibrillator models and must be applied to adult patients weighing 25 kg or more. The device is regulated under FDA 510(k) clearance (K003819) and falls under Class III classification, requiring strict adherence to high-risk medical device standards.
Frequently asked questions
Are these defibrillation pads reusable or single-use, and why does that matter in an emergency setting?
The Heartstream Attenuated Defibrillation Pads (Model M3870A) are designed as single-use devices. This is critical in emergency settings because single-use pads ensure sterility is maintained for each patient, reducing the risk of cross-contamination and infection. Reusing pads could compromise patient safety, especially in high-stress situations where time and hygiene are paramount.
What patient weight requirement applies to these pads, and how does that affect their use?
These pads are intended for adult patients weighing 25 kg (55 lbs) or more. The weight restriction ensures proper electrode placement and effective energy delivery to the heart, as smaller patients may require pediatric-specific pads for accurate defibrillation. Always verify patient weight before application to ensure safety and efficacy.
Are these pads sterile, and if not, how should they be handled to minimize infection risk?
The Heartstream Attenuated Defibrillation Pads are non-sterile by design. To minimize infection risk, follow standard aseptic techniques when applying them, such as using gloves and cleaning the patient’s chest with an alcohol swab before placement. Since they’re single-use, discard them immediately after use to prevent contamination.
Which defibrillators are compatible with these pads, and how do I confirm compatibility?
These pads are designed for use with specific defibrillator models, though the exact compatible devices aren’t listed in the data. To confirm compatibility, check the manufacturer’s documentation or consult the defibrillator’s user manual. Compatibility ensures proper energy delivery and safe operation—using mismatched pads could lead to ineffective shocks or equipment malfunctions.
What regulatory pathway was followed for this device, and what does that mean for clinicians?
The Heartstream Attenuated Defibrillation Pads (Model M3870A) were cleared via the FDA 510(k) pathway (K003819), classified as a Class III device under strict regulatory oversight. This means the device underwent rigorous pre-market review to ensure safety and effectiveness for defibrillation in cardiac arrest scenarios. Clinicians can trust its regulatory standing, though always verify compatibility with local protocols and equipment.
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: Heartstream Attenuated Defibrillation Pads, Model M3870a, PDF Defibrillation Pads - Technical Specifications - Philips, Agilent Heartstream Attenuated Defibrillation Pads, M3870a, Heartstream Attenuated Defibrillation Pads, Model M3870a
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003819 | Class III | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA 510(k) K003819 24 fields · synced Sep 18, 2026