510(k) · Cleared
ClearedWebster Duo-Decapolar Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on May 2, 2011 as substantially equivalent to K953768 (Cordis Webster, Inc., 1995) and 2 other predicates after a 292-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- May 2, 2011
- Review
- 292 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K050877 (2005). 4 ancestors in all, the oldest K953768 (1995). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK050877 Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRBiosense Webster, Inc. · 2005
- 2 generations backK090898 Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01…Biosense Webster, Inc. · 2009 · Recalled
- 1 generation backK101345 Webster CS Catheter with EZ Steer Technology, Webster CS Catheter…Biosense Webster, Inc. · 2010 · Recalled
- This deviceK101991 Webster Duo-Decapolar CatheterBiosense Webster, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK190980 Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019
- Descendant · cites it directly · 0 of its ownK240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed…Sterilmed, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233825 Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health · 2024
Most influential descendants
Showing 3 of 3 · See all- K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019 · cites it directly1descendant
- K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc. · 2024 · cites it directly0descendants
- K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050877 | Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR | Biosense Webster, Inc. | 2005 | — |
| −2 | K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS… | Biosense Webster, Inc. | 2009 | 1 |
| −1 | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ… | Biosense Webster, Inc. | 2010 | 1 |
| 0 (this device) | K101991 | Webster Duo-Decapolar Catheter | Biosense Webster, Inc. | 2011 | — |
| +1 | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | 2019 | — |
| +1 | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER®… | Sterilmed, Inc. | 2024 | — |
| +1 | K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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 DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 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 |
|---|---|---|---|
| * | K953768 | Cordis Webster A20 Diagnostic Deflectable Tip CatheterSummary page 1…Predicate Device: 1. The Cordis Webster A20 Diagnostic Deflectable Tip Catheter (510(k) K953 768) 2. The Webster CS Catheter with EZ Steer… | 1995 |
| * | K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with…Summary page 1…2. The Webster CS Catheter with EZ Steer Technology (510(k) K090898 and KIO0 1345) Manufacturing Facilities: Biosense Webster, Inc.… | 2009 |
| * | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer…Summary page 2…(5 10O(k) K953768) 2. The Webster CS Catheter with EZ Steer Technology D-1263-04 (5 10(k) K090898 and K101345) 6.2 Description of the Device Subject to Premarket Notification: The Biosense We… | 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? (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 6 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K190980 (Innovative Health, LLC, 2019) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K953768.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101991: Webster Duo-Decapolar Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101991
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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