Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Lone Star Medical Products, Inc. · Predicate Candidate Screening

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

45 daysmedian FDA review time
391 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K850041P-3 CLOSING INSTRUMENTLone Star Medical Products, Inc.1985-02-21450
K831531SURGICAL ISOLATION BARRIER SYSTEMLone Star Medical Products, Inc.1984-06-053910
K820015URETHAL CUTTER CLAMPLone Star Medical Products, Inc.1982-02-22480
K810915THE SCOTT DIALMENZENSERTLone Star Medical Products, Inc.1981-05-08320
K802983THE INQUINAL RESORVOIR INSERTERLone Star Medical Products, Inc.1980-12-30390
K791665SCOTTS SURGICAL RETRACTOR AND ELASTICLone Star Medical Products, Inc.1979-09-19290

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