Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Topera, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
219 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151245 | Rhythm View Workstation (non-streaming, steaming option) | Topera, Inc. | 2015-09-15 | 127 | 0 |
| K142901 | RhythmView Workstation | Topera, Inc. | 2014-12-19 | 66 | 0 |
| K142182 | FRIMAP ADAPTER CONNECTOR (MAC) | Topera, Inc. | 2014-09-09 | 32 | 0 |
| K133305 | RHYTHM VIEW WORKSTATION | Topera, Inc. | 2013-12-16 | 49 | 0 |
| K130827 | FIRMAP CATHETER | Topera, Inc. | 2013-10-31 | 219 | 1 |
| K123295 | RHYTHM VIEW | Topera, Inc. | 2013-04-24 | 184 | 0 |
| K110878 | RHYTHMVIEW (TM) | Topera, Inc. | 2011-09-23 | 177 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda