Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Monarch Medical Technologies — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241088 | EndoTool IV (3.1) | Monarch Medical Technologies | 2024-12-11 | 236 | 0 |
| K142918 | EndoTool SubQ | Monarch Medical Technologies | 2015-04-24 | 199 | 0 |
| K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) | Monarch Medical Technologies | 2014-04-17 | 247 | 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