Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mercator Medsystems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
178 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2021-08-02 | 178 | 0 |
| K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016-08-18 | 90 | 0 |
| K153501 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016-04-15 | 130 | 0 |
| K131401 | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER | Mercator Medsystems, Inc. | 2013-07-02 | 48 | 0 |
| K062752 | MERCATOR MICROSYRINGE II INFUSION CATHETER | Mercator Medsystems, Inc. | 2006-12-07 | 84 | 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