510(k) · Cleared
ClearedCurbell Patient Monitoring Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curbell Electronics, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Aug 27, 2008 as substantially equivalent to K942321 (Merit Cables Incorporated, 1994) after a 68-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Aug 27, 2008
- Review
- 68 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942321 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942321 Variouspatient Monitoring CableMerit Cables Incorporated · 1994
- This deviceK081762 Curbell Patient Monitoring CablesCurbell Electronics, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK181726 Medline Patient Cables and Lead WiresMedline Industries, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK243545 Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model…Philips Medizin Systeme Böblingen GmbH · 2025
- Descendant · cites it directly · 0 of its ownK182220 Curbell branded Patient Monitoring CablesCurbell Medical Products, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K181726Medline Patient Cables and Lead WiresMedline Industries, Inc. · 2018 · cites it directly1descendant
- K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…Philips Medizin Systeme Böblingen GmbH · 2025 · 2 generations on0descendants
- K182220Curbell branded Patient Monitoring CablesCurbell Medical Products, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942321 | Variouspatient Monitoring Cable | Merit Cables Incorporated | 1994 | — |
| 0 (this device) | K081762 | Curbell Patient Monitoring Cables | Curbell Electronics, Inc. | 2008 | — |
| +1 | K181726 | Medline Patient Cables and Lead Wires | Medline Industries, Inc. | 2018 | — |
| +2 | K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name… | Philips Medizin Systeme Böblingen GmbH | 2025 | — |
| +1 | K182220 | Curbell branded Patient Monitoring Cables | Curbell Medical Products, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K942321 | Variouspatient Monitoring CableSummary page 1…ducer and Electrode Cable (including connector) (21CFR870.2900, Product Code DSA) 7. Predicate device: Merit Cables, Inc. 510(k) K942321 8. Device description: Curbell Patient Monitoring Cables and Lead Wires. 9. Indications for Use: Curbell patient… | 1994 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2008, 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?
Curbell patient cables 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081762: Curbell Patient Monitoring Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081762
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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