Atlas FDA

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

Cleveland Medical Devices, Inc. · Predicate Candidate Screening

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

98 daysmedian FDA review time
155 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063872KINESIACleveland Medical Devices, Inc.2007-04-06980
K042039FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,Cleveland Medical Devices, Inc.2004-11-171110
K013863CRYSTAL MONITOR MODEL 16Cleveland Medical Devices, Inc.2002-02-19900
K001110CRYSTAL-EEG MODEL 15Cleveland Medical Devices, Inc.2000-07-05900
K970672CRYSTAL-EEG MODEL 10 (MODEL 10)Cleveland Medical Devices, Inc.1997-05-22870
K964690LIBERTY VALVECleveland Medical Devices, Inc.1997-03-211190
K962591FOOT WEIGHT ALARMCleveland Medical Devices, Inc.1996-12-041550
K954670PRESSORE MONITORCleveland Medical Devices, Inc.1995-10-30200

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