FDA applicant
Coulter Corp.
FDA records 51 decisions for Coulter Corp. (Miami, FL) from 1989 to 2000: 51 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and JPK (Mixture, Hematology Quality Control). Its devices cite 31 predicates, 16 of them its own earlier devices. 7 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Coulter Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Coulter Corp. since 2007.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Coulter Corp.’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 “Coulter”
FDA records each applicant name separately; these may or may not be the same firm.