510(k) · Cleared
ClearedZoll Aedpro with 2010 Aha Guidelines Software Update
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Mar 25, 2011 as substantially equivalent to K041892 (ZOLL Medical Corporation, 2005) after a 29-day review. Its family tree reaches back 4 generations to 2001. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 25, 2011
- Review
- 29 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003819 (2001). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
- 3 generations backK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
- 2 generations backK033474 Zoll Aed PlusZoll Medical Corp · 2004 · Recalled
- 1 generation backK041892 Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005
- This deviceK110526 Zoll Aedpro with 2010 Aha Guidelines Software UpdateZOLL Medical Corporation · 2011
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes3 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | 4 |
| −3 | K022732 | Infant/Child Reduced Energy Electrodes | Medtronic Physio-Control Corp. | 2002 | Class I |
| −2 | K033474 | Zoll Aed Plus | Zoll Medical Corp | 2004 | 1 |
| −1 | K041892 | Zoll Aed Pro External Defibrillator | ZOLL Medical Corporation | 2005 | — |
| 0 (this device) | K110526 | Zoll Aedpro with 2010 Aha Guidelines Software Update | ZOLL Medical Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K041892 | Zoll Aed Pro External DefibrillatorSummary page 3…es and functions of the proposed ZOLL AED Pro (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Pro (K041892, cleared for use on 2/4/2005). Comparison of Technological Characteristics The technological characteristics of the proposed… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K041892.
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. 2011, 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?
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by
* Unconsciousness
* Absence of breathing, and
* Absence of pulse and other signs of circulation.
When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pedi-padz II pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110526: Zoll Aedpro with 2010 Aha Guidelines Software Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110526
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026