Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sonio — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
227 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261519 | Sonio Suspect | Sonio | 2026-06-04 | 28 | 0 |
| K252433 | Sonio Detect (v3) | Sonio | 2026-03-16 | 227 | 0 |
| K243614 | Sonio Suspect | Sonio | 2025-02-21 | 91 | 0 |
| K240406 | Sonio Detect | Sonio | 2024-04-26 | 77 | 0 |
| K230365 | Sonio Detect | Sonio | 2023-07-25 | 165 | 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