# K021168: Jump Start, Model 970300

- Pathway: 510(k) (Traditional)
- Applicant: Medical Research Laboratories, Inc.
- Decided: Jun 26, 2002 after 76 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Apr 24, 2009 · Not classified · Z-1656-2009: Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experi
- Feb 26, 2009 · Not classified · Z-1389-2009: Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connec
- Dec 15, 2008 · Not classified · Z-1005-2009: Potential for device to shut down prematurely under certain circumstances.
- Dec 15, 2008 · Not classified · Z-1006-2009: Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
- Dec 15, 2008 · Not classified · Z-1007-2009: Potential for device to deliver less than the programmed energy.
- Oct 26, 2007 · Not classified · Z-0129-2008: Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient
- Apr 26, 2004 · Not classified · Z-0918-04: A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.

## Indications for use
The JUMP START is intended to be used to tréat patients in cardiopulmonary arrest. It is intended for use in either in-hospital or out-of-hospital arrests. It is intended for use by personnel who are authorized by a physician/medical director, and who have the following training and skilis: 4+ American Heart Association Heartsaver course, American Red Cross CPR/AED course, or equivalent + Training in the use of the MRL JUMP START It should only be used on patients who are unconscious, pulseless, and not breathing spontaneously. The biphasic waveform employed by the JUMP START has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. It should not be used on pediatric patients less than 8 years old.

Source page: https://510kreport.com/device/K021168
Methodology: https://510kreport.com/methodology