510(k) Report

FDA applicant

Topera, Inc.

St.Louis, MO7 decisions2011–20152 recalls

FDA records 7 decisions for Topera, Inc. (St.Louis, MO) from 2011 to 2015: 7 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and MTD (Catheter, Intracardiac Mapping, High-Density…). Its devices cite 14 predicates, 11 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Topera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 12013: 32014: 22015: 1
2011high 3 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2022

2015: 12022: 1
2011high 1 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Topera, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable5decisions
  • MTDCatheter, Intracardiac Mapping, High-Density Array2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130827Firmap CatheterTopera, Inc. · 20135cite it
  • K110878Rhythmview (TM)Topera, Inc. · 20115cite it
  • K123295Rhythm ViewTopera, Inc. · 20134cite it
  • K142901RhythmView WorkstationTopera, Inc. · 20142cite it
  • K151245Rhythm View Workstation (non-streaming, steaming option)Topera, Inc. · 20152cite it

What has FDA decided for it lately?

  • K151245Rhythm View Workstation (non-streaming, steaming option)Topera, Inc. · 2015
  • K142901RhythmView WorkstationTopera, Inc. · 2014
  • K142182Frimap Adapter Connector (Mac)Topera, Inc. · 20141 recall
  • K133305Rhythm View WorkstationTopera, Inc. · 2013
  • K130827Firmap CatheterTopera, Inc. · 20131 recall
  • K123295Rhythm ViewTopera, Inc. · 2013
  • K110878Rhythmview (TM)Topera, Inc. · 2011

All 7 as Topera, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K142182FIRMap" Catheter, 60mm BasketApr 28, 2022Class II
  • K130827FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F…Aug 12, 2015Class III