510(k) · Cleared
Recalled · 2009Jump Start, Model 970300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Research Laboratories, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jun 26, 2002 after a 76-day review. The FDA summary names no predicate by number. It has been recalled 7 times.
- Decided
- Jun 26, 2002
- Review
- 76 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 7
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2009 | Not classified | Z-1656-2009 | Labeling design | 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 experiences a flashing low battery status… |
| Feb 26, 2009 | Not classified | Z-1389-2009 | Component design/selection | 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 connection to the circuit board causing a… |
| Dec 15, 2008 | Not classified | Z-1005-2009 | Device Design | Potential for device to shut down prematurely under certain circumstances. |
| Dec 15, 2008 | Not classified | Z-1006-2009 | Component design/selection | Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm; |
| Dec 15, 2008 | Not classified | Z-1007-2009 | Process control | Potential for device to deliver less than the programmed energy. |
| Oct 26, 2007 | Not classified | Z-0129-2008 | Nonconforming Material/Component | 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 | Other | A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
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…
Read the full statement (130 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021168: Jump Start, Model 970300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021168
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026