Atlas FDA

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

Tech-Cons Ltd., Intl. — Predicate Candidate Screening

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

71 daysmedian FDA review time
97 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K843117GREEN CROSS URINARY DRAINAGE BAGTech-Cons Ltd., Intl.1984-10-11640
K843035SANG-A PETROLATUM GAUZE USP STERILETech-Cons Ltd., Intl.1984-09-20490
K842228AIMED FOLEY CATHETER VARIOUS SIZESTech-Cons Ltd., Intl.1984-09-10970
K842230AIMED DISPOS. INJECTION NEEDLETech-Cons Ltd., Intl.1984-08-17730
K842255AIMED SCALP VEIN SET VARIOUSTech-Cons Ltd., Intl.1984-08-17710
K842227AIMED DISPOSABLE SYRINGE, VARIOUS SIZESTech-Cons Ltd., Intl.1984-07-23480

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