510(k) · Cleared
ClearedIntellaMap Orion High Resolution Mapping 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 Jun 10, 2022 as substantially equivalent to K192360 (Boston Scientific Corporation, 2019) after an 84-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jun 10, 2022
- Review
- 84 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011361 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK011361 Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector CableCatheffects, LLC · 2001
- 3 generations backK122461 Rhythmia Mapping CatheterRhythmia Medical, Inc. · 2013 · Recalled
- 2 generations backK143481 IntellaMap Orion High Resolution Mapping CatheterRhythmia Medical, Inc. · 2015
- 1 generation backK192360 IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation · 2019
- This deviceK220796 IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011361 | Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector Cable | Catheffects, LLC | 2001 | — |
| −3 | K122461 | Rhythmia Mapping Catheter | Rhythmia Medical, Inc. | 2013 | 1 |
| −2 | K143481 | IntellaMap Orion High Resolution Mapping Catheter | Rhythmia Medical, Inc. | 2015 | — |
| −1 | K192360 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2019 | — |
| 0 (this device) | K220796 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K192360 | IntellaMap Orion High Resolution Mapping CatheterSummary page 4…on: 21 CFR Part 870.1220 3.Predicate Device Trade Name: IntellaMap Orion™ High Resolution Mapping Catheter Manufacturer: Boston Scientific Corporation Clearance Number: K192360 Common Name: IntellaMap Orion Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Cod… | 2019 |
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 21 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K192360.
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. 2022, 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 IntellaMap Orion Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220796: IntellaMap Orion High Resolution Mapping Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220796
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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