Atlas FDA

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

Line One Laboratories — Predicate Candidate Screening

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

88 daysmedian FDA review time
90 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991892TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLLine One Laboratories1999-08-19770
K970633TUSTEX FLAVORED CONDOMSLine One Laboratories1997-03-21290
K964598TRUSTEX COLA FLAVORD CONDOMLine One Laboratories1997-02-14880
K964599TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLORLine One Laboratories1997-02-14880
K964591TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLORLine One Laboratories1997-02-13900

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