Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sophysa — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026-04-10 | 267 | 0 |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | 2025-11-28 | 270 | 0 |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Dr | Sophysa | 2025-06-20 | 267 | 0 |
| K222422 | Polaris Valve Electronic Reading Instrument | Sophysa | 2023-02-02 | 175 | 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