Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fujifilm Irvine Scientific · 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) |
|---|---|---|---|---|---|
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | 2025-09-12 | 210 | 0 |
| K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 2024-09-26 | 136 | 0 |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | Fujifilm Irvine Scientific | 2024-04-24 | 152 | 0 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | 2023-11-09 | 142 | 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