Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DFI Co., Ltd. — 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) |
|---|---|---|---|---|---|
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent | DFI Co., Ltd. | 2018-05-23 | 35 | 0 |
| K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | 2018-02-16 | 268 | 0 |
| K102188 | CYBOW READER, MODELS 300 & 720 | DFI Co., Ltd. | 2011-08-09 | 371 | 0 |
| K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | DFI Co., Ltd. | 2006-03-29 | 196 | 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