# K122461: Rhythmia Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmia Medical, Inc.
- Decided: Apr 18, 2013 after 248 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011361 (2001). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011361: Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector Cable, Catheffects, LLC (2001) Summary page 1.

## Most influential descendants
- K143481: IntellaMap Orion High Resolution Mapping Catheter (2015), 3 descendants of its own
- K192360: IntellaMap Orion High Resolution Mapping Catheter (2019), 2 descendants of its own
- K220796: IntellaMap Orion High Resolution Mapping Catheter (2022), 0 descendants of its own
- K211662: Reprocessed IntellaMap Orion High Resolution Mapping Catheter (2021), 0 descendants of its own

## Recalls of this device
- Nov 20, 2014 · Class II · Z-0580-2015: 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.

## Indications for use
The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Source page: https://510kreport.com/device/K122461
Methodology: https://510kreport.com/methodology