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

Biodex Medical Systems, Inc. — Predicate Candidate Screening

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

276 daysmedian FDA review time
338 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330Biodex Medical Systems, Inc.2009-02-19130
K063666SHARPS CONTAINER, MODEL 039-413Biodex Medical Systems, Inc.2007-01-25450
K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APBiodex Medical Systems, Inc.1995-11-162130
K950981ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650Biodex Medical Systems, Inc.1995-04-03310
K942694STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220Biodex Medical Systems, Inc.1995-03-102760
K940301COMPEX 2Biodex Medical Systems, Inc.1994-12-283380
K935061LOWER BODY CYCLESBiodex Medical Systems, Inc.1994-09-163300
K935520UPPER BODY CYCLES (110 VOLT)/(220 VOLT)Biodex Medical Systems, Inc.1994-09-163020
K935216SEMI-RECUMBENT CYCLESBiodex Medical Systems, Inc.1994-09-163250

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