Atlas FDA

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

Biosensor Corp. — Predicate Candidate Screening

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

192 daysmedian FDA review time
640 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990956BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005Biosensor Corp.1999-06-14840
K974192BIOSENSOR HOLTER MONITOR SYSTEMBiosensor Corp.1998-03-041170
K974546BIOSENSOR HOLTER MONITOR SYSTEMBiosensor Corp.1998-03-04900
K950944AMBULATORY (HOLTER) RECORDING SYSTEMBiosensor Corp.1996-06-184870
K960449PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEBiosensor Corp.1996-05-301210
K943338BIOSENSOR BIDOP VASCULAR TEST SYSTEMBiosensor Corp.1996-04-126400
K950723AMBULATORY (HOLTER) RECORDING SYSTEMBiosensor Corp.1996-02-093580
K922027AMBULATORY (HOLTER) RECORDING, MODIFICATIONBiosensor Corp.1993-02-173280
K895266AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIEDBiosensor Corp.1990-01-261560
K831676BIOSENSOR ASC SYSTEMBiosensor Corp.1983-12-011920

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