Atlas FDA

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

Biosafe Laboratories, Inc. · Predicate Candidate Screening

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

108 daysmedian FDA review time
261 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.2004-12-151050
K012221SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPBiosafe Laboratories, Inc.2002-04-032610
K011970BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SBiosafe Laboratories, Inc.2001-09-26930
K011525SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTIBiosafe Laboratories, Inc.2001-07-16600
K003752BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROIDBiosafe Laboratories, Inc.2001-03-231080
K991850SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALCBiosafe Laboratories, Inc.1999-11-261780

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