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

Hyphen Biomed — Predicate Candidate Screening

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

316 daysmedian FDA review time
464 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071255ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040AHyphen Biomed2007-09-071263
K050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed2006-05-244640
K050365BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202Hyphen Biomed2005-12-273161
K051472BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARINHyphen Biomed2005-12-232030
K043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHHyphen Biomed2005-11-073710
K043451BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CHyphen Biomed2005-03-17930

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