510(k) · Cleared
ClearedMedtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jul 12, 2021 as substantially equivalent to K960446 (Medtronic Vascular, 1996) after a 217-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 12, 2021
- Review
- 217 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960446 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960446 Model 5471 & 5471L Sterile Disposable Patient Cable AssembliesMedtronic Vascular · 1996
- This deviceK203556 Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient CablesMedtronic, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960446 | Model 5471 & 5471L Sterile Disposable Patient Cable Assemblies | Medtronic Vascular | 1996 | — |
| 0 (this device) | K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | Medtronic, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K960446 | Model 5471 & 5471L Sterile Disposable Patient Cable AssembliesSummary page 4…ification II Regulation Number 21 CFR 870.2900 Panel Cardiovascular Predicate Device Medtronic Model 5487/5487L Disposable Patient Cables K960446 Submitter Medtronic, Inc. Cardiac Rhythm Management 8200 Coral Sea Street… | 1996 |
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?
- Its one ancestor has no recall.
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. 2021, 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 Medtronic Model 5492A, 5492V, 5492AL, 5492VL patient cables are intended for use as part of a temporary cardiac pacing system. They connect atrial and ventricular pacing lead systems to a temporary external pacemaker. They are intended for use by trained clinicians in a clinical environment. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular…
Read the full statement (119 words)
The Medtronic Model 5492A, 5492V, 5492AL, 5492VL patient cables are intended for use as part of a temporary cardiac pacing system. They connect atrial and ventricular pacing lead systems to a temporary external pacemaker. They are intended for use by trained clinicians in a clinical environment. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular stimulating instruments.
The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with:
* Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long.
* Medtronic cardiovascular stimulating instruments.
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/K203556 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203556: Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203556
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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