Atlas FDA

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

Delbio Incorporation · Predicate Candidate Screening

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

204 daysmedian FDA review time
543 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133090OXICARE FINGERTIP PULSE OXIMETERDelbio Incorporation2014-02-281510
K132338DA01 BLOOD GLUCOSE MONITORING SYSTEMDelbio Incorporation2013-10-24900
K130244DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEMDelbio Incorporation2013-08-232040
K120866DA01 BLOOD GLUCOSE MONITORING SYSTEMDelbio Incorporation2012-12-112640
K103329DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BDelbio Incorporation2012-03-134870
K113343DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEMDelbio Incorporation2012-02-08860
K100806DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUMDelbio Incorporation2011-09-165430

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