510(k) · Cleared
Recalled · Class III · 2015Firmap Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topera, Inc. · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Oct 31, 2013 as substantially equivalent to K021232 (Boston Scientific Corp, 2002) after a 219-day review. Its family tree reaches back 3 generations to 1999. 13 later devices descend from it. It has been recalled once.
- Decided
- Oct 31, 2013
- Review
- 219 days
- Class
- Class II
- Product code
- MTD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983171 (1999). 5 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 2 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 1 generation backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- This deviceK130827 Firmap CatheterTopera, 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 · cites it directly · 4 of its ownK153093 FIRMap CatheterAbbott Electrophysiology · 2016
- Descendant · 2 generations on · 3 of its ownK171583 RhythmView WorkstationAbbott Electrophysiology · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- 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
- K153093FIRMap CatheterAbbott 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 |
|---|---|---|---|---|---|
| −3 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −2 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −1 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| 0 (this device) | K130827 | Firmap Catheter | 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 | — |
| +1 | K153093 | FIRMap Catheter | Abbott Electrophysiology | 2016 | — |
| +2 | K171583 | RhythmView Workstation | Abbott Electrophysiology | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 16.4 · 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 |
|---|---|---|---|
| * | K021232 | Constellation Catheters, Model 8031MSummary page 1…recording probe * The marketed device(s) to which substantial equivalence is claimed: Constellation 510O(k) - K02 1232, cleared 05/16/2002 Device The FIRMap TM Catheter iscomprised of these major components, description… | 2002 |
What descends from it? (13)
See all 135 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2015 | Class III | Z-2478-2015 | Incorrect or no expiration date | The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 5 ancestors have a recall of any class.
- Of its descendants, K142901 (Topera, Inc., 2014) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K021232.
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. 2013, 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?
For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Topera FIRMap Tm 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/K130827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130827: Firmap Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130827
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