FDA applicant
Incstar Corp.
FDA records 59 decisions for Incstar Corp. (Stillwater, MN) from 1986 to 1997: 58 510(k) clearances and 1 original PMA approval. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and LFZ (Enzyme Linked Immunoabsorbent Assay…). Its devices cite 8 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Incstar Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Incstar Corp. since 2007.
Recalls per year
1in 2009
Class I Class II/III not classified
Planning a device like Incstar 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) Report