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 Sep 14, 2021 as substantially equivalent to K003452 (Ep Technologies, Inc., 2000) after a 124-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Sep 14, 2021
- Review
- 124 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003452 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003452 Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DEp Technologies, Inc. · 2000
- This deviceK211494 Polaris X Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2021
- Descendant · cites it directly · 0 of its ownK233207 Polaris X™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K233207Polaris X™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D | Ep Technologies, Inc. | 2000 | — |
| 0 (this device) | K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021 | — |
| +1 | K233207 | Polaris X™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DSummary page 4…or electrode recording probe (21 CFR 870.1220) Regulatory Class: II Product Code: DRF III. Predicate Device Polaris X™ Unidirectional Steerable Diagnostic Catheter, K003452 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. Device… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233207 | Polaris X™ Unidirectional Steerable Diagnostic Catheter | 2023 | 0 |
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. 2021, 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 catheter is intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211494: 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/K211494
Report an extraction error
Are you the manufacturer?
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