Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DFI — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854190 | CANTROL SPINAL FLUID CONTROL | Canyon Diagnostics, Inc. | 1985-11-25 | 41 | 0 |
| K843122 | RESOLVE-CSF | Isolab, Inc. | 1984-11-30 | 114 | 1 |
| K840974 | SOMAS HUMAN SPINAL FLUID CONTROL | Somas Medical Industries, Inc. | 1984-04-05 | 30 | 0 |
| K832821 | FIAX IGG TEST | Intl. Diagnostic Technology | 1983-10-14 | 56 | 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