Heartstramelectrode Adapter(Ea-Xx Series)/Heartstram Defibrillation Pads with Preattached Electrode Adapter(Dp-Eaxx)
510(k) K972418
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972418 | Date25 Sep 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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
This device is an Automated External Defibrillator (Non-Wearable) accessory designed to facilitate defibrillation therapy. The Heartstream Electrode Adapter (EA-XX Series) connects defibrillation pads (DP-EAXX) to defibrillators, ensuring proper electrical conduction during cardiac arrest emergencies. The preattached electrode adapters are engineered for compatibility with manual or automated defibrillators equipped with a Quick-Combo® connection system, enabling rapid deployment in critical situations.
The device is supplied as a reusable accessory for defibrillators and is intended for single-use per patient encounter, adhering to standard infection control protocols. It is classified as Class III under FDA regulations (870.5310) and has received FDA 510(k) clearance (K972418) as substantially equivalent to a predicate device. The adapters are not MRI-compatible and must be stored in a clean, dry environment to maintain functionality. Compliance with product code MKJ ensures regulatory adherence for use in cardiovascular emergency response.
Other devices from Heartstream, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these adapters designed for reuse across multiple patients, or are they intended for single-use only?
The Heartstream Electrode Adapter (EA-XX Series) and defibrillation pads with preattached adapters (DP-EAXX) are intended for single-use per patient encounter to comply with infection control protocols, despite being reusable accessories for defibrillators. This means each set should be discarded after one use to prevent cross-contamination.
What type of defibrillators are compatible with these electrode adapters, and how does the Quick-Combo® connection system improve response time?
These adapters are designed for manual or automated defibrillators equipped with a Quick-Combo® connection system, ensuring rapid and secure attachment during emergencies. The Quick-Combo® system streamlines deployment by reducing the time needed to connect pads to the defibrillator, which is critical in cardiac arrest situations where every second counts.
How should these adapters be stored to maintain their functionality and safety?
The adapters must be stored in a clean, dry environment to preserve their functionality and integrity. Since they are not MRI-compatible, they should also be kept away from magnetic fields or MRI machines to avoid potential damage or interference with their performance.
What regulatory pathway was followed for FDA clearance, and what does the product code MKJ indicate?
The Heartstream Electrode Adapter received FDA 510(k) clearance (K972418) under the traditional review pathway, demonstrating substantial equivalence to a predicate device. The product code MKJ aligns with the regulatory classification for Automated External Defibrillators (Non-Wearable) and ensures compliance with cardiovascular emergency response standards.