Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Plexus Medical — 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) |
|---|---|---|---|---|---|
| K952610 | PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500) | Plexus Medical | 1995-09-13 | 98 | 0 |
| K944411 | P/2000 | Plexus Medical | 1994-12-27 | 110 | 0 |
| K943353 | PLEXUS/1000 | Plexus Medical | 1994-12-12 | 153 | 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