# K110878: Rhythmview (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Topera, Inc.
- Decided: Sep 23, 2011 after 177 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000248 (2000). 3 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003362: Astronomer+with SLD, Boston Scientific Corp (2001) Summary page 1.
- K013083: Carto XP EP Navigation System, Biosense Webster, Inc. (2001) Summary page 1.

## Most influential descendants
- K123295: Rhythm View (2013), 8 descendants of its own
- K142901: RhythmView Workstation (2014), 6 descendants of its own
- K151245: Rhythm View Workstation (non-streaming, steaming option) (2015), 5 descendants of its own
- K161240: Rhythm View Workstation (non-streaming) (2016), 4 descendants of its own
- K171583: RhythmView Workstation (2017), 3 descendants of its own

## Indications for use
The RhythmViewTM Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmViewTM Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

Source page: https://510kreport.com/device/K110878
Methodology: https://510kreport.com/methodology