510(k) · Cleared
ClearedSureLead Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Authentic Medical · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jan 17, 2020 as substantially equivalent to K170536 (APK Technology Co., Ltd., 2017) after a 632-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jan 17, 2020
- Review
- 632 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K992524 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK992524 Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP…Advantage Medical Electronics, Inc. · 2000
- 3 generations backK082959 Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure…Unimed Medical Supplies, Inc. · 2008
- 2 generations backK120010 Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2012
- 1 generation backK170536 ECG Disposable Lead WireAPK Technology Co., Ltd. · 2017
- This deviceK181089 SureLead Cable SystemAuthentic Medical · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992524 | Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables… | Advantage Medical Electronics, Inc. | 2000 | — |
| −3 | K082959 | Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors | Unimed Medical Supplies, Inc. | 2008 | — |
| −2 | K120010 | Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2012 | — |
| −1 | K170536 | ECG Disposable Lead Wire | APK Technology Co., Ltd. | 2017 | — |
| 0 (this device) | K181089 | SureLead Cable System | Authentic Medical | 2020 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K170536 | ECG Disposable Lead WireSummary page 4…Class II (Class 2) COMMON NAME Cable / Lead-wire TRADE NAME SureLead Disposable Cable System PREDICATE DEVICES K170536 Cable/Lead-Wire (ECG). Identification of Trade Name: Surelead Disposable cable system Proposed Device… | 2017 |
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 20 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K170536.
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. 2020, 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?
The SureLead Disposable Cable System is intended to be used with ECG monitoring devices. The SureLead Disposable Cable System is used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for generating monitoring and/or diagnostic evaluation by a health 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/K181089 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181089: SureLead Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181089
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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