510(k) · Cleared
ClearedVanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanguard Medical Concepts, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Mar 18, 2003 as substantially equivalent to K910645 (Diag Corp., 1991) and 2 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Mar 18, 2003
- Review
- 75 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K882174 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK882174 Modified Model 5455 Disposable Surgical CableMedtronic Andover Medical, Inc. · 1988
- This deviceK030005 Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory…Vanguard Medical Concepts, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882174 | Modified Model 5455 Disposable Surgical Cable | Medtronic Andover Medical, Inc. | 1988 | — |
| 0 (this device) | K030005 | Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables | Vanguard Medical Concepts, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 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? (4)
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 |
|---|---|---|---|
| * | K910645 | Disposable Patient CableSummary page 1…Product Code DSA Predicate 0 Biosense Webster EP Catheter Accessory Cables (unknown) Devices DaigTMEP Catheter Accessory Cables (K910645) Medtronic EP Catheter Accessory Cables (K89498 I , K882 174) Indications for Electrophysiol… | 1991 |
| * | K894981 | Medtronic Model 5455S Disposable Surgical Cable | 1989 |
| * | K882174 | Modified Model 5455 Disposable Surgical CableSummary page 1…Cables (unknown) Devices DaigTMEP Catheter Accessory Cables (K910645) Medtronic EP Catheter Accessory Cables (K89498 I , K882 174) Indications for Electrophysiology catheter accessory cables are intended for use during Use electrop… | 1988 |
| * | — | Biosense Webster EP Catheter Accessory Cables Named without a submission number |
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?
- None of the 3 ancestors has a 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.
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?
Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030005: Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030005
Report an extraction error
Are you the manufacturer?
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