510(k) · Cleared
Recalled · Class I · 2014Padpro Model #2516
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 May 8, 2002 as substantially equivalent to K981737 (Katecho, Inc., 1998) after a 106-day review. Its family tree reaches back 1 generation to 1998. 2 of the 7 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- May 8, 2002
- Review
- 106 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 4 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981737 (1998). 5 later devices descend from it, 3 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK981737 K-Defib/Pace Adult Electrode Model Number KDP-60Katecho, Inc. · 1998
- This deviceK020203 Padpro Model #2516Padpro, LLC · 2002
- Descendant · cites it directly · 4 of its ownK080421 Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK131550 Heart SyncHeart Sync, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK103783 Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro…Fiab Spa · 2011
- Descendant · cites it directly · 0 of its ownK103334 Cardio MedCardio Medical Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK103159 Cardio Med Model A102, H104, O101, P103, and Z100Cardio Medical Products, Inc. · 2011 · Recalled
Class I recalls in this family
- K080421 Heart Sync, Models C-100 and T-100cites it directly · 2008
Most influential descendants
Showing 5 of 5 · See all- K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · cites it directly4descendants
- K131550Heart SyncHeart Sync, Inc. · 2013 · 2 generations on0descendants
- K103783Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricFiab Spa · 2011 · 2 generations on0descendants
- K103334Cardio MedCardio Medical Products, Inc. · 2011 · cites it directly0descendants
- K103159Cardio Med Model A102, H104, O101, P103, and Z100Cardio Medical Products, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60 | Katecho, Inc. | 1998 | — |
| 0 (this device) | K020203 | Padpro Model #2516 | Padpro, LLC | 2002 | — |
| +1 | K080421 | Heart Sync, Models C-100 and T-100 | Heart Sync, LLC | 2008 | Class I |
| +2 | K131550 | Heart Sync | Heart Sync, Inc. | 2013 | — |
| +2 | K103783 | Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads… | Fiab Spa | 2011 | — |
| +1 | K103334 | Cardio Med | Cardio Medical Products, Inc. | 2011 | — |
| +1 | K103159 | Cardio Med Model A102, H104, O101, P103, and Z100 | Cardio Medical Products, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2011 | 3 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60Summary page 1…on; MEN Common/Usual Name: Defibrillator Electrode . Equivalent legally marketed device: This identical in function to the Katecho KDP-60 K- Defib/Pace Adult Electrode (K981737) and nearly identical in design. Indications for Use: The PadPro Radiotranslucent (minor shadowing) external electrodes are indi… | 1998 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0457-2015 | 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… |
| Nov 6, 2014 | Class I | Z-0458-2015 | 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… |
| Mar 8, 2007 | Not classified | Z-0757-2007 | Other | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are… |
| Mar 8, 2007 | Not classified | Z-0756-2007 | Other | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are… |
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.
- K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
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 non-radiotransparent (radiotranslucent with minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. The electrode is intended for use on adult patients.…
Read the full statement (98 words)
The PadPro non-radiotransparent (radiotranslucent with minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. The electrode is intended for use on adult patients.
When a patient requires defibrillation, cardioversiofi-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 classified as low power (360 joule maximum).
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/K020203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020203: Padpro Model #2516.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020203
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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