510(k) · Cleared
ClearedPolaris X™ Unidirectional 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 Oct 27, 2023 as substantially equivalent to K211494 (Boston Scientific Corporation, 2021) after a 29-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Oct 27, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003452 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK003452 Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DEp Technologies, Inc. · 2000
- 1 generation backK211494 Polaris X Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2021
- This deviceK233207 Polaris X™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D | Ep Technologies, Inc. | 2000 | — |
| −1 | K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021 | — |
| 0 (this device) | K233207 | Polaris X™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023 | — |
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 |
|---|---|---|---|
| * | K211494 | Polaris X Unidirectional Steerable Diagnostic CatheterSummary page 5…r or electrode recording probe (21 CFR 870.1220) Regulatory Class: II Product Code: DRF 3. Predicate Device Polaris X™ Unidirectional Steerable Diagnostic Catheter, K211494 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. 4. Device… | 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 23 years and passes through 2 companies; a new generation was cleared every 20.8 years on median.
- None of the 2 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 Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233207: Polaris X™ Unidirectional 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/K233207
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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