510(k) · Cleared
ClearedCS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02
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 Apr 23, 2008 as substantially equivalent to K954390 (Cordis Webster, Inc., 1995) and 1 other predicate after a 68-day review. Its family tree reaches back 1 generation to 1984. 1 of the 10 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Apr 23, 2008
- Review
- 68 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K841802 (1984). 2 ancestors in all. 7 later devices descend from it, 4 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK841802 Electrode Catheter, Orthogonal TypeWebster Laboratories, Inc. · 1984
- This deviceK080425 CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc. · 2008
- 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 · 1 of its ownK091780 Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009
- Descendant · 2 generations on · 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)
- Descendant · cites it directly · 0 of its ownK240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed…Sterilmed, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233397 Cosine-10TM Diagnostic CatheterMedtronic, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…2 generations on · 2024
Most influential descendants
Showing 5 of 7 · See all- K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc. · 2023 · cites it directly3descendants
- K091780Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009 · cites it directly1descendant
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 2 generations on0descendants
- K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc. · 2024 · cites it directly0descendants
- K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841802 | Electrode Catheter, Orthogonal Type | Webster Laboratories, Inc. | 1984 | — |
| 0 (this device) | K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02 | Biosense Webster, Inc. | 2008 | — |
| +1 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… | Biosense Webster, Inc. | 2023 | — |
| +1 | K091780 | Guided Measurement Catheter (GMC) | Mediguide, Ltd. | 2009 | — |
| +2 | K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer… | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024 | Class I |
| +1 | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER®… | Sterilmed, Inc. | 2024 | — |
| +2 | K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | 2023 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K954390 | Cordis Wester Star CatheterSummary page 1…Recording Catheter (per 21 CFR 870.1220, Product Code DRF) Predicate Device: 1. NAVISTAR diagnostic catheter (K954390) 2. WEBSTER fixed curve catheter D-1086-566 (K841802) Manufacturing Facilities:… | 1995 |
| * | K841802 | Electrode Catheter, Orthogonal TypeSummary page 1…e DRF) Predicate Device: 1. NAVISTAR diagnostic catheter (K954390) 2. WEBSTER fixed curve catheter D-1086-566 (K841802) Manufacturing Facilities: Biosense Webster, Inc. 15715 Arrow Highway… | 1984 |
What descends from it? (7)
4 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 |
| K091780 | Guided Measurement Catheter (GMC) | 2009 | 1 |
| K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar… | 2024 | 0 |
| K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | 2018 | 0 |
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 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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. 2008, 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 CS REFSTAR Catheter is indicated for electrophysiological mapping of cardiac structures ie., recording and stimulation, including the Coronary Sinus. In addition the CS REFSTAR Catheters are used with compatible CARTO EP Navigation Systems to provide catheter tip location information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080425: CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080425
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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