Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Runbio Biotech Co.,Ltd · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One | Runbio Biotech Co.,Ltd | 2019-02-22 | 254 | 0 |
| K172627 | David Home Pregnancy Test Cassette, David Professional Pregn | Runbio Biotech Co.,Ltd | 2018-03-28 | 208 | 0 |
| K053236 | DAVID PREGNANCY TEST (MIDSTREAM) | Runbio Biotech Co.,Ltd | 2006-07-18 | 242 | 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