510(k) · Cleared
Recalled · 2007Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04,
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 Jun 22, 2010 as substantially equivalent to K090898 (Biosense Webster, Inc., 2009) after a 40-day review. Its family tree reaches back 2 generations to 2005. 1 of the 16 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 2010
- Review
- 40 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050877 (2005). 13 later devices descend from it, 9 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK050877 Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRBiosense Webster, Inc. · 2005
- 1 generation backK090898 Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01…Biosense Webster, Inc. · 2009 · Recalled
- This deviceK101345 Webster CS Catheter with EZ Steer Technology, Webster CS Catheter…Biosense Webster, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping…Biosense Webster, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK101991 Webster Duo-Decapolar CatheterBiosense Webster, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK190980 Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019
- Descendant · cites it directly · 1 of its ownK170922 Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter…Innovative Health, LLC · 2017
- 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)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…cites it directly · 2024
Most influential descendants
Showing 5 of 13 · See all- K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc. · 2023 · cites it directly3descendants
- K101991Webster Duo-Decapolar CatheterBiosense Webster, Inc. · 2011 · cites it directly3descendants
- K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019 · 2 generations on1descendant
- K170922Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS…Innovative Health, LLC · 2017 · cites it directly1descendant
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050877 | Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR | Biosense Webster, Inc. | 2005 | — |
| −1 | K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS… | Biosense Webster, Inc. | 2009 | 1 |
| 0 (this device) | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ… | Biosense Webster, Inc. | 2010 | — |
| +1 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… | Biosense Webster, Inc. | 2023 | — |
| +1 | K101991 | Webster Duo-Decapolar Catheter | Biosense Webster, Inc. | 2011 | — |
| +2 | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | 2019 | — |
| +1 | K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed… | Innovative Health, LLC | 2017 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with…Summary page 2…Webster CS Catheters with EZ Steer Technology and Webster CS Catheters with EZ Steer Technology and Auto ID cleared via 5 10(k) K090898 cleared on September 4, 2009. 5.2 Description of the Device Subject to Premnarket Notification:… | 2009 |
What descends from it? (13)
See all 139 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS… | 2023 | 3 |
| K101991 | Webster Duo-Decapolar Catheter | 2011 | 3 |
| K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS… | 2017 | 1 |
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer… Class I | 2024 | 0 |
| K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS… | 2021 | 0 |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | 2019 | 0 |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | 2015 | 0 |
| K130602 | Lasso Nav Duo Loop Catheter | 2013 | 0 |
| K121158 | Reprocessed Electrophysiology Diagnostic Catheters | 2012 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2007 | Not classified | Z-1647-2012 | Incorrect or no expiration date | The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009. |
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 5 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- 1 of the 2 ancestors has 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 K090898.
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. 2010, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K101345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101345
Report an extraction error
Are you the manufacturer?
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