510(k) · Cleared
Cleared9Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Energetic Designs, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jan 27, 2022 as substantially equivalent to K170536 (APK Technology Co., Ltd., 2017) after a 218-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jan 27, 2022
- Review
- 218 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 deviceK211941 9LineEnergetic Designs, Inc. · 2022
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) | K211941 | 9Line | Energetic Designs, Inc. | 2022 | — |
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…Applicant: APK Technology Co. Device: ECG Disposable Lead Wires 510(k) Number: K170536 7. Indications For Use 9Line patient leadwires are intended to be used to connect electrodes placed at appropriate site… | 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 22 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. 2022, 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?
9Line patient leadwires are intended to be used to connect electrodes placed at appropriate sites on the patient to an ECG or EKG monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. The device is intended for single-patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211941: 9Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211941
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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