Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Trinity Biotech, Plc — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

197 daysmedian FDA review time
219 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K014233CAPTIAM SYPHILIS-G ASSAYTrinity Biotech, Plc2002-01-24290
K011709UNI-GOLD STREP A TEST KITTrinity Biotech, Plc2001-11-081570
K001525CAPTIA SYPHILIS-G ELISA TEST SYSTEMTrinity Biotech, Plc2000-11-291970
K991697UNI-GOLD H. PYLORITrinity Biotech, Plc1999-12-212170
K982373UNI-GOLD STREP A TEST KITTrinity Biotech, Plc1999-02-112190

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