510(k) · Cleared
Recalled · 2010Heartstream Attenuated Defibrillation Pads, Model M3870A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on May 2, 2001 after a 142-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 94 devices in its family, counting itself, has a Class I recall. 93 later devices descend from it. It has been recalled 4 times.
- Decided
- May 2, 2001
- Review
- 142 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 4
- Predicates
- 0
93 later devices descend from it, 5 citing it directly. 1 of the 94 devices in this family, counting this one, has a Class I recall.
- This deviceK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001
- Descendant · cites it directly · 75 of its ownK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 72 of its ownK033474 Zoll Aed PlusZoll Medical Corp · 2004 · Recalled
- Descendant · 3 generations on · 64 of its ownK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
- Descendant · 4 generations on · 27 of its ownK090989 Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
- Descendant · 5 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodescites it directly · 2002
Most influential descendants
Showing 5 of 93 · See all- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · cites it directly75descendants
- K033474Zoll Aed PlusZoll Medical Corp · 2004 · 2 generations on72descendants
- K042007Zoll E Series DefibrillatorZoll Medical Corp · 2005 · 3 generations on64descendants
- K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009 · 4 generations on27descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | — |
| +1 | K022732 | Infant/Child Reduced Energy Electrodes | Medtronic Physio-Control Corp. | 2002 | Class I |
| +2 | K033474 | Zoll Aed Plus | Zoll Medical Corp | 2004 | 1 |
| +3 | K042007 | Zoll E Series Defibrillator | Zoll Medical Corp | 2005 | 3 |
| +4 | K090989 | Zoll R Series with Nibp and ETCO2 Options, Zoll R Series | Zoll Medical Corp | 2009 | — |
| +5 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 10 | 0 |
| 2012 | 9 | 0 |
| 2013 | 3 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (93)
See all 935 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022732 | Infant/Child Reduced Energy Electrodes Class I | 2002 | 75 |
| K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model… | 2003 | 10 |
| K033896 | Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P | 2004 | 5 |
| K111693 | Philips Heartstart FR3 Automated External Defibrillator | 2011 | 2 |
| K120536 | Heart Sync Pediatric Physio Aed Pad | 2012 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2010 | Not classified | Z-0470-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
| May 28, 2010 | Not classified | Z-0472-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
| May 28, 2010 | Not classified | Z-0473-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
| May 28, 2010 | Not classified | Z-0471-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
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 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K022732 (Medtronic Physio-Control Corp., 2002) has gone furthest, with 75 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 | — |
https://510kreport.com/device/K003819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003819: Heartstream Attenuated Defibrillation Pads, Model M3870A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003819
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026