Atlas FDA

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

Biodex Corp. — Predicate Candidate Screening

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

45 daysmedian FDA review time
175 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K915846BIODEX SYSTEM 2 AUTOPROGRAMBiodex Corp.1992-01-13310
K915648BIODEX SYSTEM 2 AUTOPROGRAMBiodex Corp.1992-01-09270
K913021BIODEX,MODEL B-2000Biodex Corp.1991-10-03860
K913020BIODEX SYSTEM 2,MODEL S2-SBiodex Corp.1991-10-03860
K900450BIODEX LIFT SIMULATORBiodex Corp.1990-07-241750
K900741BIODEX BACK SYSTEM ATTACHMENTBiodex Corp.1990-02-26100
K860821BIODEX SYSTEMBiodex Corp.1986-04-18450

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