# K142182: Frimap Adapter Connector (Mac)

- Pathway: 510(k) (Special)
- Applicant: Topera, Inc.
- Decided: Sep 9, 2014 after 32 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983171 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130827: Firmap Catheter, Topera, Inc. (2013) Summary page 5.

## Recalls of this device
- Apr 28, 2022 · Class II · Z-1213-2022: Incorrect product labeling.

## Indications for use
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.

Source page: https://510kreport.com/device/K142182
Methodology: https://510kreport.com/methodology