Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cynergy — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
64 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810566 | SIEMENS MODEL 146-146A EXTERNAL PULSE G | Cynergy | 1981-04-01 | 29 | 0 |
| K801596 | CYNERGY MODEL 184 | Cynergy | 1980-09-16 | 64 | 0 |
| K792536 | CYNERGY MODEL 182 | Cynergy | 1980-01-31 | 55 | 0 |
| K792223 | PACESETTER MODEL 350 | Cynergy | 1979-11-30 | 25 | 0 |
| K781407 | ERM-101 | Cynergy | 1978-09-27 | 44 | 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