510(k) · Cleared
ClearedOptiMap Catheter - 60mm (OPTI-CATH2-60)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortex, Inc. · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Apr 23, 2026 as substantially equivalent to K253205 (Cortex, Inc., 2026) after a 27-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Apr 23, 2026
- Review
- 27 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K983171 (1999). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 7 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 6 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 5 generations backK130827 Firmap CatheterTopera, Inc. · 2013 · Recalled
- 4 generations backK153093 FIRMap CatheterAbbott Electrophysiology · 2016
- 3 generations backK163709 FIRMap CatheterAbbott Electrophysiology · 2017
- 2 generations backK223666 Ablacath™ Mapping CatheterAblacon, Inc. · 2023
- 1 generation backK253205 OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc. · 2026
- This deviceK261012 OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −7 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −6 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −5 | K130827 | Firmap Catheter | Topera, Inc. | 2013 | 1 |
| −4 | K153093 | FIRMap Catheter | Abbott Electrophysiology | 2016 | — |
| −3 | K163709 | FIRMap Catheter | Abbott Electrophysiology | 2017 | — |
| −2 | K223666 | Ablacath™ Mapping Catheter | Ablacon, Inc. | 2023 | — |
| −1 | K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | 2026 | — |
| 0 (this device) | K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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 MTD? 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 MTD device
- #1 K231312 PENTARAY® NAV ECO High Density Mapping…score 16.5 · 7 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 |
|---|---|---|---|
| * | K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50)Summary page 5…vice Subject Device Predicate Device Predicate 510(k) OptiMap™ Catheter (OPTI-CATH2-60) OptiMap™ Catheter (OPTI-CATH2-50) K253205 K261012 - 510(k) Summary for OptiMap Catheter 1… | 2026 |
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 27 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 10 ancestors have a recall of any class.
How does its category compare?
All MTD devicesMTD Catheter, Intracardiac Mapping, High-Density Array: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MTD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MTD
66in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTD
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTD
385in 2025
MAUDE reports naming product code MTD, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 2 | — | 0 | 17 |
| 2013 | 2 | — | 0 | 30 |
| 2014 | 2 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 2 | 38 |
| 2018 | 1 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 77 |
| 2020 | 4 | 169 | 0 | 87 |
| 2021 | 1 | — | 0 | 99 |
| 2022 | 2 | — | 0 | 145 |
| 2023 | 3 | 66 | 0 | 184 |
| 2024 | 2 | — | 0 | 378 |
| 2025 | 0 | — | 0 | 385 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The OptiMapT-r Catheter is indicated for use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters). The OptiMapT-r Catheter may also be used for delivery of externally generated pacing stimuli.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261012 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261012: OptiMap Catheter - 60mm (OPTI-CATH2-60).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261012
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026