510(k) · Cleared
Recalled · Class II · 2022Frimap Adapter Connector (Mac)
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 Sep 9, 2014 as substantially equivalent to K130827 (Topera, Inc., 2013) after a 32-day review. Its family tree reaches back 4 generations to 1999. It has been recalled once.
- Decided
- Sep 9, 2014
- Review
- 32 days
- Class
- Class II
- Product code
- MTD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983171 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 3 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 2 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 1 generation backK130827 Firmap CatheterTopera, Inc. · 2013 · Recalled
- This deviceK142182 Frimap Adapter Connector (Mac)Topera, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −3 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −2 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −1 | K130827 | Firmap Catheter | Topera, Inc. | 2013 | 1 |
| 0 (this device) | K142182 | Frimap Adapter Connector (Mac) | Topera, Inc. | 2014 | — |
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 16.4 · 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 |
|---|---|---|---|
| * | K130827 | Firmap CatheterSummary page 5…High Density Array name • The marketed device(s) to which substantial equivalence is claimed: FIRMap Catheter 510(k) – K130827, cleared 10/31/2013 Device The FIRMap™ MAC is a re-usable, non-sterile, non-patient contact device description… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2022 | Class II | Z-1213-2022 | Process control | Incorrect product labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 6 ancestors have a recall of any class.
- 4 other devices also cite its predicate K130827.
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. 2014, 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 Topera FIRMap™ Mapping Adapter Connector (MAC) is indicated for use with Topera’s FIRMap™ Catheters in cardiac electrophysiology procedures. Refer to the individual Instructions for Use of the associated FIRMap Catheter. It is important to carefully review the specific indications included with the associated catheters prior to use.
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/K142182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142182: Frimap Adapter Connector (Mac).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142182
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