Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Line One Laboratories & Trading Co. · 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) |
|---|---|---|---|---|---|
| K946103 | TRUSTEX FLAVOR CONDON IN COLORS | Line One Laboratories & Trading Co. | 1996-07-15 | 579 | 0 |
| K945930 | RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPER | Line One Laboratories & Trading Co. | 1995-12-19 | 379 | 0 |
| K944786 | RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORAN | Line One Laboratories & Trading Co. | 1995-12-06 | 434 | 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