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

Meditech International, Inc. — Predicate Candidate Screening

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

218 daysmedian FDA review time
245 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081355BIOFLEX LD-R100 TREATMENT HEADMeditech International, Inc.2008-12-182180
K072551LD-I 75 AND LD-I 200Meditech International, Inc.2008-04-022050
K051875BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADSMeditech International, Inc.2006-03-132450
K041885BIOFLEX LD-175 AND LD-1200 TREATMENT HEADSMeditech International, Inc.2005-02-242270
K023621BIOFLEX PROFESSIONAL THERAPY SYSTEMMeditech International, Inc.2003-04-101630

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