510(k) · Cleared
ClearedReprocessed Webster Duo-Decapolar Diagnostic EP Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jul 1, 2019 as substantially equivalent to K101991 (Biosense Webster, Inc., 2011) after a 77-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it.
- Decided
- Jul 1, 2019
- Review
- 77 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050877 (2005). 5 ancestors in all, the oldest K953768 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK050877 Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRBiosense Webster, Inc. · 2005
- 3 generations backK090898 Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01…Biosense Webster, Inc. · 2009 · Recalled
- 2 generations backK101345 Webster CS Catheter with EZ Steer Technology, Webster CS Catheter…Biosense Webster, Inc. · 2010 · Recalled
- 1 generation backK101991 Webster Duo-Decapolar CatheterBiosense Webster, Inc. · 2011
- This deviceK190980 Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019
- Descendant · cites it directly · 0 of its ownK233825 Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health · 2024
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −4 | K050877 | Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR | Biosense Webster, Inc. | 2005 | — |
| −3 | K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS… | Biosense Webster, Inc. | 2009 | 1 |
| −2 | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ… | Biosense Webster, Inc. | 2010 | 1 |
| −1 | K101991 | Webster Duo-Decapolar Catheter | Biosense Webster, Inc. | 2011 | — |
| 0 (this device) | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | 2019 | — |
| +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 |
|---|---|---|
| 2024 | 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 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 13.7 · 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? (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 |
|---|---|---|---|
| * | K101991 | Webster Duo-Decapolar CatheterSummary page 5…0 Product Code: NLH Predicate Device: 510(k) Number 510(k) Device Manufacturer K101991 Webster Duo-Decapolar Catheter Biosense Webster Reference Device: 510(k) Number 51… | 2011 |
| † | K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | 2017 |
| † | K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | 2024 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K233825 (Innovative Health, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101991.
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. 2019, 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 Reprocessed Webster Duo-Decapolar EP 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190980: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190980
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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