510(k) · Cleared
ClearedPentaray Nav eco High-Density Mapping Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Aug 6, 2020 as substantially equivalent to K123837 (Biosense Webster, Inc., 2013) after a 41-day review. Its family tree reaches back 6 generations to 1999. 1 of the 18 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Aug 6, 2020
- Review
- 41 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983171 (1999). 12 ancestors in all, the oldest K970264 (1997). 5 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- 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 deviceK201750 Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping…Biosense Webster, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK241224 Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed…Sterilmed, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233433 Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic · 2024
- Descendant · 2 generations on · 0 of its ownK233397 Cosine-10TM Diagnostic CatheterMedtronic, Inc. · 2023
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…2 generations on · 2024
Most influential descendants
Showing 5 of 5 · See all- K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc. · 2023 · cites it directly3descendants
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 2 generations on0descendants
- K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc. · 2024 · 2 generations on0descendants
- K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic · 2024 · cites it directly0descendants
- K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc. · 2023 · 2 generations on0descendants
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) | K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020 | — |
| +1 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… | Biosense Webster, Inc. | 2023 | — |
| +2 | K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer… | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024 | Class I |
| +2 | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER®… | Sterilmed, Inc. | 2024 | — |
| +1 | K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | 2024 | — |
| +2 | K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 3 | 1 |
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.
1 device in this family has a Class I recall. 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 MTD device
- #1 K231312 PENTARAY® NAV ECO High Density Mapping…score 16.4 · 7 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 |
|---|---|---|---|
| * | K123837 | Pentaray Nav Eco High-Density Mapping CatheterSummary page 4…D-1282-08-S, D-1282-09-S, D-1282-10-S, D-1282-11-S, D-1282-12-S Predicate device PENTARAY® Nav eco Mapping Catheter (K123837) Substantially Equivalent To: The Biosense Webster Inc. PENTARAY® Nav eco Mapping Catheter is substantially e… | 2013 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 12 ancestors have a recall of any class.
- Of its descendants, K231312 (Biosense Webster, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K123837.
How does its category compare?
All MTD devicesMTD Catheter, Intracardiac Mapping, High-Density Array: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MTD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MTD
66in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTD
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTD
385in 2025
MAUDE reports naming product code MTD, 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 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 2 | — | 0 | 17 |
| 2013 | 2 | — | 0 | 30 |
| 2014 | 2 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 2 | 38 |
| 2018 | 1 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 77 |
| 2020 | 4 | 169 | 0 | 87 |
| 2021 | 1 | — | 0 | 99 |
| 2022 | 2 | — | 0 | 145 |
| 2023 | 3 | 66 | 0 | 184 |
| 2024 | 2 | — | 0 | 378 |
| 2025 | 0 | — | 0 | 385 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Biosense Webster 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. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY™ NAV eco High-Density Mapping Catheter provides location information when used with 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/K201750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201750: Pentaray Nav eco High-Density Mapping Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201750
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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