510(k) · Cleared
ClearedBLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Sep 29, 2023 as substantially equivalent to K211375 (Boston Scientific Corporation, 2021) after a 29-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Sep 29, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913375 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913375 Torque Tube Steerocath (TM)Ep Technologies, Inc. · 1991
- 2 generations backK081576 Blazer DX-20 Diagnostic CatheterBoston Scientific Corp · 2009
- 1 generation backK211375 Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2021
- This deviceK232651 BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913375 | Torque Tube Steerocath (TM) | Ep Technologies, Inc. | 1991 | — |
| −2 | K081576 | Blazer DX-20 Diagnostic Catheter | Boston Scientific Corp | 2009 | — |
| −1 | K211375 | Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021 | — |
| 0 (this device) | K232651 | BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 13.6 · 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 |
|---|---|---|---|
| * | K211375 | Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterSummary page 4…FR Part 870.1220 3. Predicate Device Trade Name: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter Manufacturer: Boston Scientific Corporation Clearance Number: K211375 Common Name: Blazer Dx-20 Diagnostic Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Prod… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 4 ancestors has a recall.
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. 2023, 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 Blazer Dx-20 Catheter is indicated for use to diagnose cardiac arrhythmia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232651: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232651
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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