510(k) · Cleared
Recalled · Class I · 2018Pad Pro Pediatric Electrode, Model Pad Pro 2602
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Devices, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Feb 5, 2001 after a 194-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 6 times, including a Class I recall.
- Decided
- Feb 5, 2001
- Review
- 194 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 6 (1 Class I)
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK002280 Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK020288 Padpro, Model 2603Padpro, LLC · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK081442 Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 2008
- Descendant · 3 generations on · 0 of its ownK120536 Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK103783 Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro…Fiab Spa · 2011
Class I recalls in this family
- K020288 Padpro, Model 2603cites it directly · 2002
Most influential descendants
Showing 4 of 4 · See all- K020288Padpro, Model 2603Padpro, LLC · 2002 · cites it directly3descendants
- K081442Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 2008 · 2 generations on2descendants
- K120536Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012 · 3 generations on0descendants
- K103783Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricFiab Spa · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602 | Medical Devices, Inc. | 2001 | — |
| +1 | K020288 | Padpro, Model 2603 | Padpro, LLC | 2002 | Class I |
| +2 | K081442 | Heart Sync Pediatric, Model Ped-100 | Heart Sync, LLC | 2008 | — |
| +3 | K120536 | Heart Sync Pediatric Physio Aed Pad | Heart Sync, Inc. | 2012 | — |
| +3 | K103783 | Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads… | Fiab Spa | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 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.
2 devices in this family have 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020288 | Padpro, Model 2603 Class I | 2002 | 3 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2018 | Class II | Z-1178-2018 | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure |
| Feb 23, 2018 | Class II | Z-1176-2018 | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure |
| Feb 23, 2018 | Class II | Z-1177-2018 | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure |
| Feb 23, 2018 | Class II | Z-1175-2018 | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure |
| Feb 23, 2018 | Class II | Z-1174-2018 | Process design | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure |
| Nov 6, 2014 | Class I | Z-0460-2015 | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient… |
The 5 latest of 6 recalls; the web page lists all.
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.
- K020288Padpro, Model 2603Padpro, LLC · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020288 (Padpro, LLC, 2002) has gone furthest, with 3 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/K002280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002280: Pad Pro Pediatric Electrode, Model Pad Pro 2602.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002280
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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