510(k) · Cleared

Cleared

Cardio Med

K103334510(k) TraditionalCleared Jan 18, 201164-day reviewClass II21 CFR 870.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardio Medical Products, Inc. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

Cleared on Jan 18, 2011 as substantially equivalent to K080421 (Heart Sync, LLC, 2008) and 2 other predicates after a 64-day review. Its family tree reaches back 3 generations to 1998. 2 of the 4 devices in its family, counting itself, have a Class I recall.

Decided: Jan 18, 2011
Review: 64 days
Class: Class II
Product code: LDD
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K981737 (1998). No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.

By dateBy generation

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 deviceK103334 Cardio MedCardio Medical Products, Inc. · 2011

Class I recalls in this family

K080421 Heart Sync, Models C-100 and T-100direct predicate · 2008
K020203 Padpro Model #2516direct predicate · 2002

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)	K103334	Cardio Med	Cardio Medical Products, Inc.	2011	—

FIG. 1 — Lineage of K103334, 1998–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K080421	Heart Sync, Models C-100 and T-100 Summary page 1 …ification name: 870.5300 DC-defibrillator (including paddles). (3) Predicate devices: Identical in function and construction to the Heart Sync Electrodes described in K(080421, as well as PadPro (K(020203), and Katecho (K981737). (4) Description of the device: These are single use, non-sterile, self st…	Heart Sync, LLC	2008	Class I
*	K020203	Padpro Model #2516 Summary page 1 …efibrillator (including paddles). (3) Predicate devices: Identical in function and construction to the Heart Sync Electrodes described in K(080421, as well as PadPro (K(020203), and Katecho (K981737). (4) Description of the device: These are single use, non-sterile, self stick defibrillator electrodes…	Padpro, LLC	2002	Class I
*	K981737	K-Defib/Pace Adult Electrode Model Number KDP-60 Summary page 1 …g paddles). (3) Predicate devices: Identical in function and construction to the Heart Sync Electrodes described in K(080421, as well as PadPro (K(020203), and Katecho (K981737). (4) Description of the device: These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. 104…	Katecho, Inc.	1998	—

Also cleared against K080421: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.

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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls

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.
2 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
3 other devices also cite its predicate K080421.

How does its category compare?

All LDD devices

LDD 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

2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDD

124in 2011

2007high 124 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LDD

2in 2024

2007high 11 (2008) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LDD

74in 2025

2007high 1,214 (2008) · low 19 (2020)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?

Read the full statement (119 words)

The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG 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 adult patients. 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 Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIC-CONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103334 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103334: Cardio Med.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103334

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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