510(k) · Cleared

Cleared

Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors

K082959510(k) TraditionalCleared Oct 10, 20087-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

Unimed Medical Supplies, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)

Cleared on Oct 10, 2008 as substantially equivalent to K992524 (Advantage Medical Electronics, Inc., 2000) after a 7-day review. Its family tree reaches back 1 generation to 2000. 21 later devices descend from it.

Decided: Oct 10, 2008
Review: 7 days
Class: Class II
Product code: DSA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K992524 (2000). 21 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK992524 Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP…Advantage Medical Electronics, Inc. · 2000
This deviceK082959 Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure…Unimed Medical Supplies, Inc. · 2008
Descendant · cites it directly · 17 of its ownK120010 Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2012
Descendant · cites it directly · 2 of its ownK203635 Patient Monitoring CablesJkh USA, LLC · 2021
Descendant · 2 generations on · 2 of its ownK192404 Patient Monitoring Cable (SpO2 Extension Cable)Shenzhen Coreray Technology, Ltd. · 2020
Descendant · cites it directly · 2 of its ownK162768 ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2…Integral Process Sas · 2017
Descendant · 2 generations on · 2 of its ownK170536 ECG Disposable Lead WireAPK Technology Co., Ltd. · 2017

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2012high 4 (2020) · low 0 (2013)2026

Most influential descendants

Showing 5 of 21 · See all

K120010Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2012 · cites it directly17descendants
K203635Patient Monitoring CablesJkh USA, LLC · 2021 · cites it directly2descendants
K192404Patient Monitoring Cable (SpO2 Extension Cable)Shenzhen Coreray Technology, Ltd. · 2020 · 2 generations on2descendants
K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP…Integral Process Sas · 2017 · cites it directly2descendants
K170536ECG Disposable Lead WireAPK Technology Co., Ltd. · 2017 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992524	Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables…	Advantage Medical Electronics, Inc.	2000	—
0 (this device)	K082959	Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors	Unimed Medical Supplies, Inc.	2008	—
+1	K120010	Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)	Shenzhen Med-Link Electronics Tech Co., Ltd.	2012	—
+1	K203635	Patient Monitoring Cables	Jkh USA, LLC	2021	—
+2	K192404	Patient Monitoring Cable (SpO2 Extension Cable)	Shenzhen Coreray Technology, Ltd.	2020	—
+1	K162768	ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and…	Integral Process Sas	2017	—
+2	K170536	ECG Disposable Lead Wire	APK Technology Co., Ltd.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2017	2	0
2018	2	0
2019	2	0
2020	4	0
2021	2	0
2022	2	0
2023	2	0
2024	1	0
2025	3	0

FIG. 1 — Lineage of K082959, 2000–2025Source: 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? (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	Applicant	Decided	Recalls
*	K992524	Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and Leadwires Summary page 1 …mon Name: Patient Cables and Lead wires Product Classification: Class II: Cardiovascular 74 DSA, per 21 CFR section 870.2900 Predicate Device: Advantage Medical Cables: K992524 Description: Unlined's most common cable lead wire configuration ECG cables with specific various length are the replacements f…	Advantage Medical Electronics, Inc.	2000	—

Also cleared against K992524: 2 other devices →

What descends from it? (21)

See all 21

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120010	Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)	Shenzhen Med-Link Electronics Tech Co., Ltd.	2012	17
K203635	Patient Monitoring Cables	Jkh USA, LLC	2021	2
K162768	ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP…	Integral Process Sas	2017	2

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?

Its one ancestor has no recall.
Of its descendants, K120010 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2012) has gone furthest, with 17 descendants of its own.
2 other devices also cite its predicate K992524.

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. 2008, 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?

The Unimed patient cables and lead wires are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The patient cables and lead wires are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082959 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082959: Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082959

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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