FDA applicant
Streck
FDA records 38 decisions for Streck (La Vista, NE) from 2005 to 2026: 37 510(k) clearances and 1 De Novo grant. Most are in product codes JPK (Mixture, Hematology Quality Control) and KRX (Calibrator For Cell Indices). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 23 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Streck, Inc.”, “Streck, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Streck’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Streck’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 “Streck”
FDA records each applicant name separately; these may or may not be the same firm.