Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QFX · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
271 daysmedian FDA review time
445 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2026-01-21 | 271 | 0 |
| K240215 | BLUE 400; BLUE 400 S | Carl Zeiss Meditec, AG | 2024-06-28 | 154 | 0 |
| K232567 | Myriad SPECTRA Light Source | Nico Corporation | 2024-03-14 | 203 | 1 |
| K211346 | BLUE 400 | Carl Zeiss Meditec, AG | 2022-07-22 | 445 | 0 |
| DEN180024 | Leica FL400 | Leica Microsystems (Schweiz) AG | 2019-03-28 | 335 | 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