510(k) · Cleared
ClearedZoll Aed Pro External Defibrillator
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 Feb 4, 2005 as substantially equivalent to K011541 (Zoll Medical Corp, 2002) and 2 other predicates after a 206-day review. Its family tree reaches back 3 generations to 2001. 1 of the 29 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Feb 4, 2005
- Review
- 206 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003819 (2001). 5 ancestors in all. 23 later devices descend from it, 2 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
- 2 generations backK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
- 1 generation backK033474 Zoll Aed PlusZoll Medical Corp · 2004 · Recalled
- This deviceK041892 Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005
- Descendant · cites it directly · 21 of its ownK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
- Descendant · 2 generations on · 11 of its ownK100654 Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010
- Descendant · 2 generations on · 9 of its ownK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
- Descendant · 3 generations on · 9 of its ownK102468 Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010
- Descendant · 4 generations on · 8 of its ownK112432 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes2 generations back · 2002
Most influential descendants
Showing 5 of 23 · See all- K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · cites it directly21descendants
- K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010 · 2 generations on11descendants
- K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · 2 generations on9descendants
- K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010 · 3 generations on9descendants
- K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | 4 |
| −2 | K022732 | Infant/Child Reduced Energy Electrodes | Medtronic Physio-Control Corp. | 2002 | Class I |
| −1 | K033474 | Zoll Aed Plus | Zoll Medical Corp | 2004 | 1 |
| 0 (this device) | K041892 | Zoll Aed Pro External Defibrillator | ZOLL Medical Corporation | 2005 | — |
| +1 | K060559 | Zoll R Series Defibrillator | ZOLL Medical Corporation | 2006 | 1 |
| +2 | K100654 | Zoll Propaq MD | Zoll Medical Corporation, World Wide Headquarters | 2010 | — |
| +2 | K110742 | Onestep Adult Multi-Function Electrode | ZOLL Medical Corporation | 2011 | 1 |
| +3 | K102468 | Zoll Propaq MD | Zoll Medical Corporation, World Wide Headquarters | 2010 | — |
| +4 | K112432 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K011541 | Zoll Pad with CPR AidSummary page 1…The features and functions of the ZOLL AED Pro External Defibrillator are substantially equivalent to those of the ZOLL AED Plus with CPR Aid: 510(k) No. K011541, cleared 4/11/2002, the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004 and the Philips Medical Systems, Heartstart FR2… | 2002 |
| * | K033474 | Zoll Aed PlusSummary page 1…nal Defibrillator are substantially equivalent to those of the ZOLL AED Plus with CPR Aid: 510(k) No. K011541, cleared 4/11/2002, the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004 and the Philips Medical Systems, Heartstart FR2+ (formerly Heartstream ForeRunner), 510(k) No. K0134… | 2004 |
| * | K013425 | Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841ASummary page 1…1/2002, the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004 and the Philips Medical Systems, Heartstart FR2+ (formerly Heartstream ForeRunner), 510(k) No. K013425, cleared 1/14/2002. Description: The ZOLL AED Pro External Defibrillator is a portable, battery powered, automated e… | 2002 |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K060559 (ZOLL Medical Corporation, 2006) has gone furthest, with 21 descendants of its own.
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?
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by: * Unconsciousness, and * Absence of normal breathing, and * Absence of a pulse or signs of circulation. When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should be used with ZOLL pedi-padz II defibrillation electrodes. Therapy should not be delayed to determine the patient's exact…
Read the full statement (199 words)
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by:
* Unconsciousness, and
* Absence of normal breathing, and
* Absence of a pulse or signs of circulation.
When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should be used with ZOLL pedi-padz II defibrillation electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
At the discretion of the rescuer, the Monitoring Mode feature can be used with the AED Pro ECG Cable to provide a non-diagnostic display of a breathing or responsive patient's ECG rhythm, regardless of their age. While connected to the AED Pro ECG Cable, the AED Pro performs a background analysis the patient's rhythm and disables its defibrillator feature.
Contraindications for Use - Defibrillation
Do not use the AED Pro unit for defibrillation when the patient
* Is conscious; or
* Is breathing; or
* Has a detectable pulse or other signs of circulation.
Contraindications for Use - CPR Monitoring
The CPR monitoring function is not intended for use on patients under 8 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041892 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041892: Zoll Aed Pro External Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041892
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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