510(k) · Cleared
ClearedPENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
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 Jul 10, 2023 as substantially equivalent to K201750 (Biosense Webster, Inc., 2020) and 2 other predicates after a 66-day review. Its family tree reaches back 7 generations to 1999. 1 of the 23 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jul 10, 2023
- Review
- 66 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K983171 (1999). 19 ancestors in all, the oldest K841802 (1984). 3 later devices descend from it, 3 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 6 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 5 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 4 generations backK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- 3 generations backK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- 2 generations backK123837 Pentaray Nav Eco High-Density Mapping CatheterBiosense Webster, Inc. · 2013 · Recalled
- 1 generation backK201750 Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc. · 2020
- This deviceK231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping…Biosense Webster, Inc. · 2023
- Descendant · cites it directly · 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 · cites it directly · 0 of its ownK240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed…Sterilmed, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233397 Cosine-10TM Diagnostic CatheterMedtronic, Inc. · 2023
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…cites it directly · 2024
Most influential descendants
Showing 3 of 3 · See all- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · cites it directly0descendants
- K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc. · 2024 · cites it directly0descendants
- K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −6 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −5 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −4 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| −3 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| −2 | K123837 | Pentaray Nav Eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2013 | 5 |
| −1 | K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020 | — |
| 0 (this device) | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… | Biosense Webster, Inc. | 2023 | — |
| +1 | K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer… | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024 | Class I |
| +1 | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER®… | Sterilmed, Inc. | 2024 | — |
| +1 | K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 K253205 OptiMap Catheter - 50mm (OPTI-CATH2-50)score 15.8 · 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? (3)
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 |
|---|---|---|---|
| * | K201750 | Pentaray Nav eco High-Density Mapping CatheterSummary page 5…AV eco High Density Mapping Catheter: PENTARAY® NAV eco High Density Mapping Catheter, cleared via 510(k) K201750 DECANAV® Mapping Catheter: DECANAV® Mapping Catheter, cleared via 510(k)… | 2020 |
| * | K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Summary page 5…K201750 DECANAV® Mapping Catheter: DECANAV® Mapping Catheter, cleared via 510(k) K080425 Webster® CS Catheter with Auto ID: Webster® CS Catheter with Auto ID, in… | 2008 |
| * | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer…Summary page 5…® CS Catheter with EZ Steer Technology: Webster® CS Catheter with EZ Steer Technology, cleared via 510(k) K101345 Webster® CS Catheter with EZ Steer Technology with Auto ID: Webster® CS… | 2010 |
What descends from it? (3)
3 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 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 19 ancestors have a recall of any class.
- Of its descendants, K241224 (Surgical Instrument Service and Savings Inc.(Dba Medline Ren, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201750.
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. 2023, 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?
PENTARAY® NAYV 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…
Read the full statement (139 words)
PENTARAY® NAYV 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).
The DECANAV® Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the coronary sinus. In addition, the catheter is used with compatible CARTO® 3 System to provide catheter tip location information.
The Webster® CS Catheter is indicated for electrophysiological mapping of cardiac structures i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
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/K231312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231312: PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231312
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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