Atlas FDA

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

Galix Biomedical Instrumentation, Inc. — Predicate Candidate Screening

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

271 daysmedian FDA review time
581 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K0928533 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SGalix Biomedical Instrumentation, Inc.2010-07-092960
K051163GALIX ECG PROFESSIONAL STATIONGalix Biomedical Instrumentation, Inc.2006-01-312710
K030145GALIX WINTERGalix Biomedical Instrumentation, Inc.2003-09-172450
K023080GALIX PACESTARGalix Biomedical Instrumentation, Inc.2003-06-112670
K992706GALIX GBI -3S-LPGalix Biomedical Instrumentation, Inc.2001-03-155810
K9716703 CHANNEL DIGITAL AMBULATORY ECG RECORDERGalix Biomedical Instrumentation, Inc.1998-01-292680

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