510(k) · Cleared
ClearedReprocessed DecaNav Diagnostic Electrophysiology Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Jun 19, 2018 as substantially equivalent to K080425 (Biosense Webster, Inc., 2008) after a 92-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Jun 19, 2018
- Review
- 92 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K841802 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK841802 Electrode Catheter, Orthogonal TypeWebster Laboratories, Inc. · 1984
- 1 generation backK080425 CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc. · 2008
- This deviceK180710 Reprocessed DecaNav Diagnostic Electrophysiology CatheterInnovative Health, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841802 | Electrode Catheter, Orthogonal Type | Webster Laboratories, Inc. | 1984 | — |
| −1 | K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02 | Biosense Webster, Inc. | 2008 | — |
| 0 (this device) | K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 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 |
|---|---|---|---|
| * | K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Summary page 5…Code: NLH Predicate Device: 510(k) Number 510(k) Title Manufacturer K080425 CS RefStar Catheter Biosense Webster Device Description: The Repr… | 2008 |
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 23.5 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K080425.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus.
The catheter provides tip location information when used with the compatible Carto 3 EP Navigation Systems.
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/K180710 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180710: Reprocessed DecaNav Diagnostic Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180710
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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