510(k) · Cleared
Recalled · Class I · 2014Padpro, Model 2603
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Padpro, LLC · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Feb 27, 2002 as substantially equivalent to K002280 (Medical Devices, Inc., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 2 of the 5 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Feb 27, 2002
- Review
- 30 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002280 (2001). 3 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.
- Root · 1 generation backK002280 Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 2001 · Recalled (Class I)
- This deviceK020288 Padpro, Model 2603Padpro, LLC · 2002
- Descendant · cites it directly · 2 of its ownK081442 Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK120536 Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012
- Descendant · 2 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
- K002280 Pad Pro Pediatric Electrode, Model Pad Pro 2602direct predicate · 2001
Most influential descendants
Showing 3 of 3 · See all- K081442Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 2008 · cites it directly2descendants
- K120536Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012 · 2 generations on0descendants
- K103783Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricFiab Spa · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602 | Medical Devices, Inc. | 2001 | Class I |
| 0 (this device) | K020288 | Padpro, Model 2603 | Padpro, LLC | 2002 | — |
| +1 | K081442 | Heart Sync Pediatric, Model Ped-100 | Heart Sync, LLC | 2008 | — |
| +2 | K120536 | Heart Sync Pediatric Physio Aed Pad | Heart Sync, Inc. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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.
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? (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 |
|---|---|---|---|
| * | K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602Summary page 1…sual Name: Defibrillator Electrode Equivalent legally marketed device: This identical in function and nearly identical in design to the PadPro 2602 Pediatric Electrode (K002280). Indications for Use: The PadPro pediatric electrodes are indicated for use in external pacing, defibrillation and monitoring a… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081442 | Heart Sync Pediatric, Model Ped-100 | 2008 | 2 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2014 | Class I | Z-0459-2015 | 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… |
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.
- K002280Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- Of its descendants, K081442 (Heart Sync, LLC, 2008) has gone furthest, with 2 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?
The PadPro pediatric electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use only. The PadPro 2603 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patient’s skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg…
Read the full statement (125 words)
The PadPro pediatric electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use only. The PadPro 2603 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patient’s skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg (22 Ibs).
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is can be limited to 30 joules maximum. The PadPro 2603 pediatric electrodes are designed for, and to be used with the Physio-control, Zoll, and Hewlett Packard defibrillators.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020288: Padpro, Model 2603.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020288
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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