510(k) · Cleared
ClearedReprocessed PentaRay Nav eco High-Density Mapping Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed
Cleared on Jun 25, 2019 as substantially equivalent to K123837 (Biosense Webster, Inc., 2013) after a 90-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Jun 25, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- NLG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983171 (1999). 12 ancestors in all, the oldest K970264 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 5 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 4 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 3 generations backK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- 2 generations backK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- 1 generation backK123837 Pentaray Nav Eco High-Density Mapping CatheterBiosense Webster, Inc. · 2013 · Recalled
- This deviceK190785 Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative Health, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −5 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −4 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −3 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| −2 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| −1 | K123837 | Pentaray Nav Eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2013 | 5 |
| 0 (this device) | K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Innovative Health, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 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 NLG? 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 NLG device
- #1 K212776 Reprocessed Advisor HD Grid Mapping Catheter…score 4.3 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K123837 | Pentaray Nav Eco High-Density Mapping CatheterSummary page 5…Product Code: NLG Predicate Device: 510(k) Number 510(k) Title Manufacturer K123837 PentaRay NAV eco High-Density Mapping Biosense Webster, Inc. Catheter… | 2013 |
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 20 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 12 ancestors have a recall of any class.
- 3 other devices also cite its predicate K123837.
How does its category compare?
All NLG devicesNLG Catheter, Intracardiac Mapping, High-Density, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NLG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NLG
Too few NLG 510(k)s in any year since 2007 to give a median.
Recalls per year · NLG
No recall names NLG since 2007.
Adverse event reports per year · NLG
2in 2025
MAUDE reports naming product code NLG, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190785: Reprocessed PentaRay Nav eco High-Density Mapping Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190785
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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