510(k) · Cleared
Recalled · 2011Cordis Webster A20 Diagnostic Deflectable Tip Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Nov 22, 1995 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 22, 1995
- Review
- 100 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 4
- Predicates
- 0
10 later devices descend from it, 7 citing it directly.
- This deviceK953768 Cordis Webster A20 Diagnostic Deflectable Tip CatheterCordis Webster, Inc. · 1995
- 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 · 2 generations on · 0 of its ownK240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed…Sterilmed, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233825 Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health · 2024
- Descendant · cites it directly · 0 of its ownK171788 Reprocessed Halo XP Diagnostic Electrophysiology CatheterInnovative Health, LLC · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K101991Webster Duo-Decapolar CatheterBiosense Webster, Inc. · 2011 · cites it directly3descendants
- K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC · 2019 · 2 generations on1descendant
- K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc. · 2024 · 2 generations on0descendants
- K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health · 2024 · 2 generations on0descendants
- K171788Reprocessed Halo XP Diagnostic Electrophysiology CatheterInnovative Health, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953768 | Cordis Webster A20 Diagnostic Deflectable Tip Catheter | Cordis Webster, Inc. | 1995 | — |
| +1 | K101991 | Webster Duo-Decapolar Catheter | Biosense Webster, Inc. | 2011 | — |
| +2 | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | 2019 | — |
| +2 | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER®… | Sterilmed, Inc. | 2024 | — |
| +2 | K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health | 2024 | — |
| +1 | K171788 | Reprocessed Halo XP Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101991 | Webster Duo-Decapolar Catheter | 2011 | 3 |
| K171788 | Reprocessed Halo XP Diagnostic Electrophysiology Catheter | 2017 | 0 |
| K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | 2017 | 0 |
| K043513 | Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheter | 2005 | 0 |
| K012678 | Reprocessed Sealed Electrophysiology Diagnostic Catheters | 2002 | 0 |
| K012523 | Reprocessed Electrophysiology Diagnostic Catheters | 2002 | 0 |
| K012520 | Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20E | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2011 | Not classified | Z-2664-2011 | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. |
| May 23, 2011 | Not classified | Z-2665-2011 | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. |
| Apr 29, 2011 | Not classified | Z-3038-2011 | Labeling Change Control | The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions… |
| Apr 29, 2011 | Not classified | Z-3037-2011 | Labeling Change Control | The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101991 (Biosense Webster, Inc., 2011) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K953768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953768: Cordis Webster A20 Diagnostic Deflectable Tip Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953768
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026