FDA applicant
George King Bio-Medical, Inc.
FDA records 5 decisions for George King Bio-Medical, Inc. (Overland Park, KS) from 1995 to 2017: 5 510(k) clearances. Most are in product codes GGN (Plasma, Coagulation Control) and GJT (Plasma, Coagulation Factor Deficient). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided George King Bio-Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like George King Bio-Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “George”
FDA records each applicant name separately; these may or may not be the same firm.