510(k) · Cleared
ClearedMedline Patient Cables and Lead Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Sep 20, 2018 as substantially equivalent to K081762 (Curbell Electronics, Inc., 2008) after an 83-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Sep 20, 2018
- Review
- 83 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942321 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK942321 Variouspatient Monitoring CableMerit Cables Incorporated · 1994
- 1 generation backK081762 Curbell Patient Monitoring CablesCurbell Electronics, Inc. · 2008
- This deviceK181726 Medline Patient Cables and Lead WiresMedline Industries, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK243545 Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model…Philips Medizin Systeme Böblingen GmbH · 2025
Most influential descendants
Showing 1 of 1 · See all- K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…Philips Medizin Systeme Böblingen GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942321 | Variouspatient Monitoring Cable | Merit Cables Incorporated | 1994 | — |
| −1 | K081762 | Curbell Patient Monitoring Cables | Curbell Electronics, Inc. | 2008 | — |
| 0 (this device) | K181726 | Medline Patient Cables and Lead Wires | Medline Industries, Inc. | 2018 | — |
| +1 | K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name… | Philips Medizin Systeme Böblingen GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K081762 | Curbell Patient Monitoring CablesSummary page 4…most suitable for comparison with Medline Patient Cables and Lead Wires is: Curbell Patient Monitoring Cables and Lead Wires. This device was cleared under 510(k) number K081762 on August 18th, 2008 to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device f… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171… | 2025 | 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 24 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243545 (Philips Medizin Systeme Böblingen GmbH, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081762.
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. 2018, 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?
Medline Patient Cables and Lead Wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. Additionally, the use of Medline Patient Cables and Lead Wires is limited by the indications for use of the ECG monitoring or diagnostic equipment it is connected to. Medline Patient Cables and Lead Wires are intended for Prescription Use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181726: Medline Patient Cables and 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/K181726
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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