510(k) · Cleared
ClearedEuro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiab Spa · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Jun 16, 2011 as substantially equivalent to K080421 (Heart Sync, LLC, 2008) and 1 other predicate after a 171-day review. Its family tree reaches back 3 generations to 1998. 4 of the 7 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 16, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981737 (1998). 6 ancestors in all. No later device cites it as a predicate yet. 4 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK981737 K-Defib/Pace Adult Electrode Model Number KDP-60Katecho, Inc. · 1998
- 2 generations backK020203 Padpro Model #2516Padpro, LLC · 2002 · Recalled (Class I)
- 1 generation backK080421 Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Recalled (Class I)
- This deviceK103783 Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro…Fiab Spa · 2011
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60 | Katecho, Inc. | 1998 | — |
| −2 | K020203 | Padpro Model #2516 | Padpro, LLC | 2002 | Class I |
| −1 | K080421 | Heart Sync, Models C-100 and T-100 | Heart Sync, LLC | 2008 | Class I |
| 0 (this device) | K103783 | Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads… | Fiab Spa | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2002 | 1 | 1 |
| 2008 | 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.
4 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? (2)
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 |
|---|---|---|---|
| * | K080421 | Heart Sync, Models C-100 and T-100Summary page 1…r 1510(K) number Adult Radiotranslucent Multi-function Electrodes Heart Sync LLC K08042l Adult Radiotransparent Multi-function Electrodes Heart Sync LLC K080421 Pediatric Radiotranslucent Multi-function Electrodes Heart Sync LLC K081442 Device description FLAB EURO DEFI PADS series of… | 2008 |
| * | K081442 | Heart Sync Pediatric, Model Ped-100Summary page 1…Sync LLC K08042l Adult Radiotransparent Multi-function Electrodes Heart Sync LLC K080421 Pediatric Radiotranslucent Multi-function Electrodes Heart Sync LLC K081442 Device description FLAB EURO DEFI PADS series of disposable multi-fiunction electrodes arc made by a couple of pre-gelled self-a… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
- K020203Padpro Model #2516Padpro, LLC · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K020288Padpro, Model 2603Padpro, LLC · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K002280Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 6 ancestors have a recall of any class; 4 have a Class I recall.
- 3 other devices also cite its predicate K080421.
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. 2011, 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?
EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications: - external defibrillation - synchronized cardioversion - cardiac stimulation - ECG monitoring EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different…
Read the full statement (170 words)
EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications:
- external defibrillation
- synchronized cardioversion
- cardiac stimulation
- ECG monitoring
EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only.
The pediatric model of EURO DELI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule.
The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule.
The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103783: Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103783
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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