510(k) · Cleared
ClearedRhythmview (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topera, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Sep 23, 2011 as substantially equivalent to K003362 (Boston Scientific Corp, 2001) and 1 other predicate after a 177-day review. Its family tree reaches back 2 generations to 2000. 9 later devices descend from it.
- Decided
- Sep 23, 2011
- Review
- 177 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000248 (2000). 3 ancestors in all. 9 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 1 generation backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- This deviceK110878 Rhythmview (TM)Topera, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK123295 Rhythm ViewTopera, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK142901 RhythmView WorkstationTopera, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK151245 Rhythm View Workstation (non-streaming, steaming option)Topera, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK161240 Rhythm View Workstation (non-streaming)Abbott Electrophysiology · 2016
- Descendant · 2 generations on · 3 of its ownK171583 RhythmView WorkstationAbbott Electrophysiology · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K123295Rhythm ViewTopera, Inc. · 2013 · cites it directly8descendants
- K142901RhythmView WorkstationTopera, Inc. · 2014 · cites it directly6descendants
- K151245Rhythm View Workstation (non-streaming, steaming option)Topera, Inc. · 2015 · cites it directly5descendants
- K161240Rhythm View Workstation (non-streaming)Abbott Electrophysiology · 2016 · cites it directly4descendants
- K171583RhythmView WorkstationAbbott Electrophysiology · 2017 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −1 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| 0 (this device) | K110878 | Rhythmview (TM) | Topera, Inc. | 2011 | — |
| +1 | K123295 | Rhythm View | Topera, Inc. | 2013 | — |
| +1 | K142901 | RhythmView Workstation | Topera, Inc. | 2014 | — |
| +1 | K151245 | Rhythm View Workstation (non-streaming, steaming option) | Topera, Inc. | 2015 | — |
| +1 | K161240 | Rhythm View Workstation (non-streaming) | Abbott Electrophysiology | 2016 | — |
| +2 | K171583 | RhythmView Workstation | Abbott Electrophysiology | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003362 | Astronomer+with SLDSummary page 1…@Programmable diagnostic computer The marketed device(s) to which substantial equivalence is claimed: * Astronomer + (K003362) * CARTO XP Mapping System (K013083) Device The RhythmView is comprised of these major components,… | 2001 |
| * | K013083 | Carto XP EP Navigation SystemSummary page 1…The marketed device(s) to which substantial equivalence is claimed: * Astronomer + (K003362) * CARTO XP Mapping System (K013083) Device The RhythmView is comprised of these major components, description 1. RhythmView hardw… | 2001 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123295 (Topera, Inc., 2013) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K003362.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110878 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110878: Rhythmview (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110878
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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