510(k) · Cleared
ClearedHeart Sync Pediatric, Model Ped-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heart Sync, LLC · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Sep 24, 2008 as substantially equivalent to K020288 (Padpro, LLC, 2002) after a 125-day review. Its family tree reaches back 2 generations to 2001. 2 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Sep 24, 2008
- Review
- 125 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002280 (2001). 2 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK002280 Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 2001 · Recalled (Class I)
- 1 generation backK020288 Padpro, Model 2603Padpro, LLC · 2002 · Recalled (Class I)
- This deviceK081442 Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 2008
- Descendant · cites it directly · 0 of its ownK120536 Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK103783 Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro…Fiab Spa · 2011
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602 | Medical Devices, Inc. | 2001 | Class I |
| −1 | K020288 | Padpro, Model 2603 | Padpro, LLC | 2002 | Class I |
| 0 (this device) | K081442 | Heart Sync Pediatric, Model Ped-100 | Heart Sync, LLC | 2008 | — |
| +1 | K120536 | Heart Sync Pediatric Physio Aed Pad | Heart Sync, Inc. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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.
Top candidate predicates for a new LDD device
- #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K020288 | Padpro, Model 2603Summary page 1…fication Name: DC-defibrillator Common/Usual Name: Defibrillator Electrode 2. Equivalent legally marketed devices: This is identical in function to the Pad Pro K020288. 3. Indications for Use: The Heart Sync Pediatric Radiotranslucent Multifunction Electrodes are indicated for use in ex… | 2002 |
What descends from it? (2)
2 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)
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.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K120536 (Heart Sync, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, 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 | 0 | — | 0 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Heart Sync Pediatric Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient 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 pediatric patients whose weight is less…
Read the full statement (123 words)
The Heart Sync Pediatric Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient 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 pediatric patients whose weight is less than 25 kg. 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 classified as low power (360 joule maximum).
Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081442: Heart Sync Pediatric, Model Ped-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081442
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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