510(k) · Cleared
ClearedBlazer DX-20 Diagnostic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Feb 3, 2009 as substantially equivalent to K940168 (Ep Technologies, Inc., 1994) and 1 other predicate after a 243-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Feb 3, 2009
- Review
- 243 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913375 (1991). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913375 Torque Tube Steerocath (TM)Ep Technologies, Inc. · 1991
- This deviceK081576 Blazer DX-20 Diagnostic CatheterBoston Scientific Corp · 2009
- Descendant · cites it directly · 1 of its ownK211375 Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK232651 BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023
- Descendant · cites it directly · 0 of its ownK230503 Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific · 2023
Most influential descendants
Showing 3 of 3 · See all- K211375Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2021 · cites it directly1descendant
- K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023 · 2 generations on0descendants
- K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913375 | Torque Tube Steerocath (TM) | Ep Technologies, Inc. | 1991 | — |
| 0 (this device) | K081576 | Blazer DX-20 Diagnostic Catheter | Boston Scientific Corp | 2009 | — |
| +1 | K211375 | Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021 | — |
| +2 | K232651 | BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023 | — |
| +1 | K230503 | Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable | Boston Scientific | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 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 13.7 · 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? (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 |
|---|---|---|---|
| * | K940168 | Diagnostic II CatheterSummary page 1…dicate Device Information Table 2: Predicate Device Information Category:,.. !'~,'~'.'.:. '.Comments: Predicate Device: SteeroCath Dx Diagnostic Catheter (K940168/ K913375) Predicate Device Manufacturer: Boston Scientific Corporation Predicate Device Common N… | 1994 |
| * | K913375 | Torque Tube Steerocath (TM)Summary page 1…cate Device Information Category:,.. !'~,'~'.'.:. '.Comments: Predicate Device: SteeroCath Dx Diagnostic Catheter (K940168/ K913375) Predicate Device Manufacturer: Boston Scientific Corporation Predicate Device Common Name: Electrode recording and pacing cathe… | 1991 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2009, 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 is a diagnostic catheter indicated for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081576: Blazer DX-20 Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081576
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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