Atlas FDA

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

Loredan Biomedical, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
250 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K924512LIDO V-TAKLoredan Biomedical, Inc.1993-05-122500
K924513LIDO(R) LINEALoredan Biomedical, Inc.1993-03-312080
K903429LIDO LINEALoredan Biomedical, Inc.1990-08-14140
K884487LIDO TM ACTIVE BACKLoredan Biomedical, Inc.1988-11-18240
K880017LIDO(TM) LIFTLoredan Biomedical, Inc.1988-02-26520
K880018LIDO(TM) WORKSETLoredan Biomedical, Inc.1988-02-26520
K871793LIDO ACTIVELoredan Biomedical, Inc.1987-06-05290
K861986LIDO BACKLoredan Biomedical, Inc.1986-06-02110
K832770LANE ONELoredan Biomedical, Inc.1983-09-26410

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