510(k) · Cleared
ClearedVariouspatient Monitoring Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Cables Incorporated · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Nov 4, 1994 after a 175-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 4, 1994
- Review
- 175 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK942321 Variouspatient Monitoring CableMerit Cables Incorporated · 1994
- Descendant · cites it directly · 3 of its ownK081762 Curbell Patient Monitoring CablesCurbell Electronics, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK181726 Medline Patient Cables and Lead WiresMedline Industries, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK243545 Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model…Philips Medizin Systeme Böblingen GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK182220 Curbell branded Patient Monitoring CablesCurbell Medical Products, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK093657 Adagio Retracting Ecg Lead WiresAcist Medical Systems, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K081762Curbell Patient Monitoring CablesCurbell Electronics, Inc. · 2008 · cites it directly3descendants
- K181726Medline Patient Cables and Lead WiresMedline Industries, Inc. · 2018 · 2 generations on1descendant
- K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…Philips Medizin Systeme Böblingen GmbH · 2025 · 3 generations on0descendants
- K182220Curbell branded Patient Monitoring CablesCurbell Medical Products, Inc. · 2018 · 2 generations on0descendants
- K093657Adagio Retracting Ecg Lead WiresAcist Medical Systems, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942321 | Variouspatient Monitoring Cable | Merit Cables Incorporated | 1994 | — |
| +1 | K081762 | Curbell Patient Monitoring Cables | Curbell Electronics, Inc. | 2008 | — |
| +2 | K181726 | Medline Patient Cables and Lead Wires | Medline Industries, Inc. | 2018 | — |
| +3 | K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name… | Philips Medizin Systeme Böblingen GmbH | 2025 | — |
| +2 | K182220 | Curbell branded Patient Monitoring Cables | Curbell Medical Products, Inc. | 2018 | — |
| +1 | K093657 | Adagio Retracting Ecg Lead Wires | Acist Medical Systems, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K081762 (Curbell Electronics, Inc., 2008) has gone furthest, with 3 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K942321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942321: Variouspatient Monitoring Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942321
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026