510(k) · Cleared

Cleared

Ecg Cables, Trunk and Patient Lead Wires

K070232510(k) AbbreviatedCleared Mar 27, 200762-day reviewClass II21 CFR 870.2900

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

American I.V. Products, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)

Cleared on Mar 27, 2007 as substantially equivalent to K945034 (Conmedcorp, 1994) and 5 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1994.

Decided: Mar 27, 2007
Review: 62 days
Class: Class II
Product code: DSA
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K920790 (1994). 9 ancestors in all, the oldest K921669 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK920790 Marquette Eagle MonitorMarquette Electronics, Inc. · 1994
1 generation backK960418 Eagle Patient MonitorMarquette Electronics, Inc. · 1996
This deviceK070232 Ecg Cables, Trunk and Patient Lead WiresAmerican I.V. Products, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K920790	Marquette Eagle Monitor	Marquette Electronics, Inc.	1994	—
−1	K960418	Eagle Patient Monitor	Marquette Electronics, Inc.	1996	—
0 (this device)	K070232	Ecg Cables, Trunk and Patient Lead Wires	American I.V. Products, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	2	0
1995	1	0
1997	2	0
1998	1	0

FIG. 1 — Lineage of K070232, 1994–2007Source: 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.

Planning a device in DSA? 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 DSA device

#1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (6)

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
*	K945034	Conmed Ecg Patient Safety Cables and Leadwires-Removal and Permanently-Attached Leadwires Summary page 1 …Name: ECG Cables, Trunk and Patient Lead Wires Predicate Device: These AIV devices are substantially equivalent to the following legally marketed devices: ConMed Corp: K945034, K933649 FSR1311, FSR565, FSR1303, FSR1534, FSR1390, FSR1590, FSR367, FSR1370, FSR1539, D833811, D8538, FSP24-003R, DA24-0311, FS…	Conmedcorp	1994	—
*	K933649	Conmed Ecg Patient Cables and Leadwires Summary page 1 …Cables, Trunk and Patient Lead Wires Predicate Device: These AIV devices are substantially equivalent to the following legally marketed devices: ConMed Corp: K945034, K933649 FSR1311, FSR565, FSR1303, FSR1534, FSR1390, FSR1590, FSR367, FSR1370, FSR1539, D833811, D8538, FSP24-003R, DA24-0311, FSA24-003R,…	Conmedcorp	1994	—
*	K980582	Multi-Link Cable and Lead Wire Systems Summary page 1 …, FSR1390, FSR1590, FSR367, FSR1370, FSR1539, D833811, D8538, FSP24-003R, DA24-0311, FSA24-003R, DL24-0311, FSP24-005R, DA24-05, FSA24- 005R, DL24-05 GE Medical Systems: K980582, K970545, K964750, K960418 2017003-001, 411203-001, 411202-001, 412682-001, 412681-001 Description: AIV's Electrocardiograph (E…	Marquette Medical Systems, Inc.	1998	—
*	K970545	Dash 1000 Patient Monitor Summary page 1 …, FSR1590, FSR367, FSR1370, FSR1539, D833811, D8538, FSP24-003R, DA24-0311, FSA24-003R, DL24-0311, FSP24-005R, DA24-05, FSA24- 005R, DL24-05 GE Medical Systems: K980582, K970545, K964750, K960418 2017003-001, 411203-001, 411202-001, 412682-001, 412681-001 Description: AIV's Electrocardiograph (ECG) cable…	Marquette Medical Systems, Inc.	1997	—
*	K964750	Eagle 4000 Patient Monitor Summary page 1 …, FSR367, FSR1370, FSR1539, D833811, D8538, FSP24-003R, DA24-0311, FSA24-003R, DL24-0311, FSP24-005R, DA24-05, FSA24- 005R, DL24-05 GE Medical Systems: K980582, K970545, K964750, K960418 2017003-001, 411203-001, 411202-001, 412682-001, 412681-001 Description: AIV's Electrocardiograph (ECG) cables (also s…	Marquette Electronics, Inc.	1997	—
*	K960418	Eagle Patient Monitor Summary page 1 …FSR1370, FSR1539, D833811, D8538, FSP24-003R, DA24-0311, FSA24-003R, DL24-0311, FSP24-005R, DA24-05, FSA24- 005R, DL24-05 GE Medical Systems: K980582, K970545, K964750, K960418 2017003-001, 411203-001, 411202-001, 412682-001, 412681-001 Description: AIV's Electrocardiograph (ECG) cables (also sometimes…	Marquette Electronics, Inc.	1996	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
None of the 9 ancestors has a recall.

How does its category compare?

All DSA devices

DSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DSA

4in 2025

2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSA

105in 2025

2007high 240 (2023) · low 55 (2010)2026

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

Recalls per year · DSA

1in 2022

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSA

67in 2025

2007high 67 (2014) · low 1 (2010)2025

MAUDE reports naming product code DSA, 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	2	—	0	4
2008	6	59	0	11
2009	0	—	0	5
2010	4	55	2	1
2011	1	—	0	4
2012	1	—	0	8
2013	1	—	0	23
2014	1	—	0	67
2015	0	—	0	34
2016	2	—	0	28
2017	5	140	0	5
2018	3	84	0	16
2019	4	140	0	11
2020	6	177	0	31
2021	4	164	0	7
2022	2	—	1	49
2023	3	240	0	29
2024	3	102	0	40
2025	4	105	0	67
2026	1	—	0	—

What is it indicated for?

These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. They are solely intended to be used between the disposable electrodes (not manufactured by AIV) in contact with the patient's skin and the recording/monitoring device (not manufactured by AIV). These cables are used by qualified personnel in the field of Cardiology for diagnostic and monitoring purposes. AIV cables are limited by the Indications for Use of the connected recording/monitoring device. No other usage is intended for the trunk cables or leadwires.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070232 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070232: Ecg Cables, Trunk and Patient Lead Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070232

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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