510(k) · Cleared
ClearedReprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Oct 11, 2024 as substantially equivalent to K080425 (Biosense Webster, Inc., 2008) and 2 other predicates after a 199-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Oct 11, 2024
- Review
- 199 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K983171 (1999). 22 ancestors in all, the oldest K841802 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 7 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 6 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 5 generations backK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- 4 generations backK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- 3 generations backK123837 Pentaray Nav Eco High-Density Mapping CatheterBiosense Webster, Inc. · 2013 · Recalled
- 2 generations backK201750 Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc. · 2020
- 1 generation backK231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping…Biosense Webster, Inc. · 2023
- This deviceK240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed…Sterilmed, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −7 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −6 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −5 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| −4 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| −3 | K123837 | Pentaray Nav Eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2013 | 5 |
| −2 | 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 | — |
| 0 (this device) | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER®… | Sterilmed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 2 | 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 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Summary page 6…Class II, 21 CFR 870.1220 Classification: Product Code NLH Primary Predicate Biosense Webster CS RefStar™ (DECANAV) Catheter (K080425) Device: Secondary Biosense Webster CS RefStar™ (DECANAV) Catheter (K231312) Predicate Devices:… | 2008 |
| * | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Summary page 6…Predicate Biosense Webster CS RefStar™ (DECANAV) Catheter (K080425) Device: Secondary Biosense Webster CS RefStar™ (DECANAV) Catheter (K231312) Predicate Devices: Biosense Webster Duo-Decapolar Catheter (K101991) The Reprocessed… | 2023 |
| * | K101991 | Webster Duo-Decapolar CatheterSummary page 6…Device: Secondary Biosense Webster CS RefStar™ (DECANAV) Catheter (K231312) Predicate Devices: Biosense Webster Duo-Decapolar Catheter (K101991) The Reprocessed DECANAV™ Catheter is a sterile, single patient use… | 2011 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 11 of the 22 ancestors have a recall of any class.
- 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. 2024, 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 DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.
The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240826 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240826: Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar 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/K240826
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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