Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Auris Health, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
205 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260382 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2026-07-25 | 170 | 0 |
| K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025-01-23 | 108 | 1 |
| K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022-04-29 | 205 | 1 |
| K211493 | Monarch Platform | Auris Health, Inc. | 2021-07-09 | 57 | 2 |
| K193534 | Monarch Platform | Auris Health, Inc. | 2020-04-15 | 117 | 4 |
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