510(k) · Cleared
ClearedCoronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR
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 24, 2005 after a 79-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 17 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- Jun 24, 2005
- Review
- 79 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
16 later devices descend from it, 2 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- This deviceK050877 Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRBiosense Webster, Inc. · 2005
- Descendant · cites it directly · 14 of its ownK090898 Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01…Biosense Webster, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 13 of its ownK101345 Webster CS Catheter with EZ Steer Technology, Webster CS Catheter…Biosense Webster, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping…Biosense Webster, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK101991 Webster Duo-Decapolar CatheterBiosense Webster, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK190980 Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…3 generations on · 2024
Most influential descendants
Showing 5 of 16 · See all- K090898Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with…Biosense Webster, Inc. · 2009 · cites it directly14descendants
- K101345Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer…Biosense Webster, Inc. · 2010 · 2 generations on13descendants
- K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc. · 2023 · 3 generations on3descendants
- K101991Webster Duo-Decapolar CatheterBiosense Webster, Inc. · 2011 · 2 generations on3descendants
- K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ… | Biosense Webster, Inc. | 2010 | 1 |
| +3 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… | Biosense Webster, Inc. | 2023 | — |
| +2 | K101991 | Webster Duo-Decapolar Catheter | Biosense Webster, Inc. | 2011 | — |
| +3 | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 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 13.7 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K892265 | Biosense Webster Deflectable Mapping Catheter Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…lectrode Recording Catheter (21 CFR 870.1220) Device Class: II Product code: DRF Predicate device: K892265 Biosense Webster Deflectable Mapping Catheter Product Description: The Coronary Sinus Defl… |
What descends from it? (16)
See all 162 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 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K090898 (Biosense Webster, Inc., 2009) has gone furthest, with 14 descendants of its own.
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.
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 Coronary Sinus Deflectable Mapping Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050877 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050877: Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050877
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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