510(k) · Cleared
Recalled · Class II · 2014Rhythmia Mapping Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhythmia Medical, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Apr 18, 2013 as substantially equivalent to K011361 (Catheffects, LLC, 2001) after a 248-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 18, 2013
- Review
- 248 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011361 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011361 Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector CableCatheffects, LLC · 2001
- This deviceK122461 Rhythmia Mapping CatheterRhythmia Medical, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK143481 IntellaMap Orion High Resolution Mapping CatheterRhythmia Medical, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK192360 IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK220796 IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK211662 Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K143481IntellaMap Orion High Resolution Mapping CatheterRhythmia Medical, Inc. · 2015 · cites it directly3descendants
- K192360IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation · 2019 · 2 generations on2descendants
- K220796IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation · 2022 · 3 generations on0descendants
- K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011361 | Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector Cable | Catheffects, LLC | 2001 | — |
| 0 (this device) | K122461 | Rhythmia Mapping Catheter | Rhythmia Medical, Inc. | 2013 | — |
| +1 | K143481 | IntellaMap Orion High Resolution Mapping Catheter | Rhythmia Medical, Inc. | 2015 | — |
| +2 | K192360 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2019 | — |
| +3 | K220796 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2022 | — |
| +3 | K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Innovative Health, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K011361 | Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector CableSummary page 1…I mapping (recording or stimulating only) of the cardiac structures of the heart. 1.3 Predicate Device Desai VectorCath Tm Mapping Catheter K011361 Manufactured by CathEffects 1.4 Engineering Part Number The Rhythmia Mapping Catheter Model ID RM-CO0101 is being referred t… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143481 | IntellaMap Orion High Resolution Mapping Catheter | 2015 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2014 | Class II | Z-0580-2015 | Device Design | Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field. |
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. 2013, 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 Rhythmia Mapping 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/K122461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122461: Rhythmia 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/K122461
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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