510(k) · Cleared
ClearedOptiMap™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DQK Computer, Diagnostic, Programmable
Cleared on May 28, 2025 as substantially equivalent to K230008 (Ablacon, Inc., 2023) after a 28-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- May 28, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K000248 (2000). 29 ancestors in all, the oldest K874441 (1988). No later device cites it as a predicate yet.
- Root · 10 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 6 generations between
- 3 generations backK171583 RhythmView WorkstationAbbott Electrophysiology · 2017
- 2 generations backK203084 Ablamap SoftwareAblacon, Inc. · 2021
- 1 generation backK230008 Ablamap® SystemAblacon, Inc. · 2023
- This deviceK251344 OptiMap™ SystemBoston Scientific Corporation · 2025
Show all 10 generations
- Root · 10 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 9 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 8 generations backK110878 Rhythmview (TM)Topera, Inc. · 2011
- 7 generations backK123295 Rhythm ViewTopera, Inc. · 2013
- 6 generations backK142901 RhythmView WorkstationTopera, Inc. · 2014
- 5 generations backK151245 Rhythm View Workstation (non-streaming, steaming option)Topera, Inc. · 2015
- 4 generations backK161240 Rhythm View Workstation (non-streaming)Abbott Electrophysiology · 2016
- 3 generations backK171583 RhythmView WorkstationAbbott Electrophysiology · 2017
- 2 generations backK203084 Ablamap SoftwareAblacon, Inc. · 2021
- 1 generation backK230008 Ablamap® SystemAblacon, Inc. · 2023
- This deviceK251344 OptiMap™ SystemBoston Scientific Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −9 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −8 | K110878 | Rhythmview (TM) | Topera, Inc. | 2011 | — |
| −7 | K123295 | Rhythm View | Topera, Inc. | 2013 | — |
| −6 | K142901 | RhythmView Workstation | Topera, Inc. | 2014 | — |
| −5 | K151245 | Rhythm View Workstation (non-streaming, steaming option) | Topera, Inc. | 2015 | — |
| −4 | K161240 | Rhythm View Workstation (non-streaming) | Abbott Electrophysiology | 2016 | — |
| −3 | K171583 | RhythmView Workstation | Abbott Electrophysiology | 2017 | — |
| −2 | K203084 | Ablamap Software | Ablacon, Inc. | 2021 | — |
| −1 | K230008 | Ablamap® System | Ablacon, Inc. | 2023 | — |
| 0 (this device) | K251344 | OptiMap™ System | Boston Scientific Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 26.7 · 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? (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 |
|---|---|---|---|
| * | K230008 | Ablamap® SystemSummary page 5….1425): Programmable diagnostic computer 510(k) Number: K251344 III. Predicate Device Information Predicate Device: Ablamap® System Manufacturer: Ablacon, Inc. 510(k): K230008 FDA Clearance Date: June 8th, 2023 Product Code: DQK Device Class: Class II Classification Regulation: (21 CFR 870.1425): Program… | 2023 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 29 ancestors have a recall of any class.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251344: OptiMap™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251344
Report an extraction error
Are you the manufacturer?
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