510(k) · Cleared
ClearedMobileaed, Mobileals, Mobileaed+ and Advantageaed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concord Medical Products · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Apr 1, 2010 after a 239-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 1, 2010
- Review
- 239 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Medtronic PhysicControl LifePak 500 Named without a submission number | |
| * | — | Cardiac Science Powerheart G3 Named without a submission number | |
| * | — | Zoll AED Pro Named without a submission number | |
| * | — | Philips Heartstream FR2+ Named without a submission 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)
No FDA recall names this device.
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. 2010, this device’s year, is highlighted.
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 Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device. When the patient is a child or infant, up to 8 years…
Read the full statement (234 words)
The Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device.
When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg), the Concord Medical Pediatric Defibrillation Pad which attenuates the energy should be used. Therapy should not be delayed to determine the patient's exact age or weight.
The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 lbs (251Kg).
The MobileALS and MobileAED+ products are the same as the MobileAED with an option to provide manual control for defibrillation for use by advanced cardiac life support (ALS) users.
The rescuer may use the ECG monitoring node cable feature to provide a non-diagnostic ECG rhythm display of a breathing or responsive patient regardless of age. Connection of the ECG monitoring mode cable disables the defibrillation feature and allows ECC analysis either in background or by pressing the analyze button.
Contraindications for Use - Defibrillation
Do not use the MobileAED for defibrillation when the patient;
Is conscious; or
Is breathing; or
Has a detectable pulse or other signs of circulation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092391: Mobileaed, Mobileals, Mobileaed+ and Advantageaed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092391
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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