# K020984: Accessaed, Semi-Automatic External Defibrillators

- Pathway: 510(k) (Traditional)
- Applicant: Access Cardiosystems, Inc.
- Decided: Aug 14, 2002 after 149 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943301 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003565: Heartstream FR2 Aed, Model M3860A,M3861A, Agilent Technologies, Inc. (2000) Summary page 1.
- K983393: Lifepak 500 Biphasic, Physio-Control Corp. (1999) Summary page 1.
- K990762: Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic), Zoll Medical Corp (1999) Summary page 1.

## Recalls of this device
- Nov 3, 2004 · Not classified · Z-0199-05: Device may fail to deliver shock due to a faulty circuit board
- Dec 19, 2003 · Not classified · Z-0356-04: Difibrillator may fail to operate due to a faulty component on the circuit board

## Indications for use
The AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse. The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level, synchronization, and shock delivery. In the semi-automatic mode, AccessALS functions identically to the AccessAED. The AccessAED and AccessALS are not currently indicated for children less than 8 years old (less than approximately 25 kgs. or 55 lbs.) The use of the AccessAED and AccessALS should be reviewed after each event and all adverse events should be reported.

Source page: https://510kreport.com/device/K020984
Methodology: https://510kreport.com/methodology