Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Opsens, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
278 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251367 | OptoMonitor 3 | Opsens, Inc. | 2026-01-16 | 260 | 0 |
| K241418 | OptoMonitor 3 | Opsens, Inc. | 2025-02-12 | 268 | 0 |
| K240864 | PacePro Wire | Opsens, Inc. | 2024-05-24 | 57 | 0 |
| K213854 | SavvyWire | Opsens, Inc. | 2022-09-14 | 278 | 0 |
| K202943 | OptoMonitor 3 | Opsens, Inc. | 2020-11-24 | 55 | 0 |
| K193620 | OptoMonitor 3 | Opsens, Inc. | 2020-06-18 | 175 | 0 |
| K191907 | OptoWire III | Opsens, Inc. | 2020-01-02 | 170 | 0 |
| K192340 | OptoMonitor | Opsens, Inc. | 2019-12-12 | 106 | 0 |
| K161263 | OptoMonitor II | Opsens, Inc. | 2016-09-13 | 131 | 0 |
| K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015-06-12 | 270 | 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