510(k) · Cleared
ClearedCable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Med-Link Electronics Tech Co., Ltd. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jan 19, 2012 as substantially equivalent to K082959 (Unimed Medical Supplies, Inc., 2008) and 1 other predicate after a 16-day review. Its family tree reaches back 2 generations to 2000. 17 later devices descend from it.
- Decided
- Jan 19, 2012
- Review
- 16 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K992524 (2000). 17 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK992524 Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP…Advantage Medical Electronics, Inc. · 2000
- 1 generation backK082959 Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure…Unimed Medical Supplies, Inc. · 2008
- This deviceK120010 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 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 · cites it directly · 2 of its ownK170536 ECG Disposable Lead WireAPK Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK222370 SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK191428 ECG CableShenzhen Changke Connect Electronics Co., Ltd. · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K192404Patient Monitoring Cable (SpO2 Extension Cable)Shenzhen Coreray Technology, Ltd. · 2020 · cites it directly2descendants
- 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 · cites it directly2descendants
- K222370SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd. · 2023 · 2 generations on1descendant
- K191428ECG CableShenzhen Changke Connect Electronics Co., Ltd. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992524 | Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables… | Advantage Medical Electronics, Inc. | 2000 | — |
| −1 | K082959 | Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors | Unimed Medical Supplies, Inc. | 2008 | — |
| 0 (this device) | K120010 | Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2012 | — |
| +1 | 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 | — |
| +1 | K170536 | ECG Disposable Lead Wire | APK Technology Co., Ltd. | 2017 | — |
| +2 | K222370 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2023 | — |
| +1 | K191428 | ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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.
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
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 |
|---|---|---|---|
| * | K082959 | Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure MonitorsSummary page 5…1006VM U708-40 L:2.4m L2.4m L:2.2m Conclusion: * Shenzhen Med-link design is equivalent to predicate devices cleared to market under 510(k) K082959 and K992524. * Electrical safety and bench Testing confirms that Subject device performs as intended. * The proposed device does… | 2008 |
| * | K992524 | Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and LeadwiresSummary page 5…U708-40 L:2.4m L2.4m L:2.2m Conclusion: * Shenzhen Med-link design is equivalent to predicate devices cleared to market under 510(k) K082959 and K992524. * Electrical safety and bench Testing confirms that Subject device performs as intended. * The proposed device does not raise ne… | 2000 |
What descends from it? (17)
See all 1710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192404 | Patient Monitoring Cable (SpO2 Extension Cable) | 2020 | 2 |
| K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP… | 2017 | 2 |
| K170536 | ECG Disposable Lead Wire | 2017 | 2 |
| K191428 | ECG Cable | 2019 | 1 |
| K220447 | Med-link Disposable ECG Cable and Leadwires | 2022 | 0 |
| K200722 | PCA-C1 series Patient Cable | 2021 | 0 |
| K201359 | ECG Cables and Leadwires | 2020 | 0 |
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | 2019 | 0 |
| K182220 | Curbell branded Patient Monitoring Cables | 2018 | 0 |
| K172797 | ECG Cable/Leadwires | 2018 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192404 (Shenzhen Coreray Technology, Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K082959.
How does its category compare?
All DSA devicesDSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DSA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSA
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSA
67in 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?
Shenzhen Med-link Cable / lead-wire are intended to be used with ECG, EKG, SpO2 and Invasive Blood Pressure monitoring devices. The Cable / lead-wire 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120010: Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120010
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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