510(k) · Cleared
Recalled · Class II · 2016Vanguard Reprocessed Diagnostic Electrophysiology Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanguard Medical Concepts, Inc. · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Mar 9, 2005 as substantially equivalent to K022380 (St Jude Medical, 2002) after a 219-day review. Its family tree reaches back 1 generation to 2002. It has been recalled once.
- Decided
- Mar 9, 2005
- Review
- 219 days
- Class
- Class II
- Product code
- NLH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022380 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK022380 Livesire Electrophysiology CatheterSt Jude Medical · 2002
- This deviceK042074 Vanguard Reprocessed Diagnostic Electrophysiology CathetersVanguard Medical Concepts, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022380 | Livesire Electrophysiology Catheter | St Jude Medical | 2002 | — |
| 0 (this device) | K042074 | Vanguard Reprocessed Diagnostic Electrophysiology Catheters | Vanguard Medical Concepts, Inc. | 2005 | — |
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 NLH? 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 NLH device
- #1 K252405 Medline ReNewal Reprocessed Boston Scientific…score 10.4 · 1 generation · 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 |
|---|---|---|---|
| * | K022380 | Livesire Electrophysiology CatheterSummary page 1…uct Code NLH Predicate * St. Jude Medical, Daig Division, LivewireT"' Steerable Diagonostic Devices Catheters (K0223 80) Indications for This catheter is intended for temporary intracardiac pacing and recording Ulse… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2016 | Class II | Z-0380-2017 | Under Investigation by firm | The EP Catheters may be mislabeled for French size during reprocessing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K022380.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NLH
165in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLH
28so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NLH
66in 2025
MAUDE reports naming product code NLH, 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 | 0 | — | 0 | 1 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 120 | 0 | 8 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 6 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 11 | 133 | 3 | 25 |
| 2017 | 4 | 138 | 0 | 11 |
| 2018 | 4 | 122 | 4 | 21 |
| 2019 | 4 | 195 | 0 | 38 |
| 2020 | 2 | — | 0 | 28 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 1 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 30 |
| 2024 | 6 | 165 | 0 | 47 |
| 2025 | 2 | — | 0 | 66 |
| 2026 | 0 | — | 28 (1) | — |
What is it indicated for?
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042074: Vanguard Reprocessed Diagnostic Electrophysiology Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042074
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