Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stat Path — 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) |
|---|---|---|---|---|---|
| K890042 | MICROSCOPE SLIDES PRECOATED | Stat Path | 1989-01-13 | 8 | 0 |
| K882362 | STAT FIX MICROWAVE IRRADIATION MEDIUM | Stat Path | 1988-06-22 | 15 | 0 |
| K882357 | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY | Stat Path | 1988-06-16 | 9 | 0 |
| K881477 | HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED | Stat Path | 1988-04-18 | 11 | 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