510(k) Report

FDA applicant

Mast Immunosystems

Mountain View, CA13 decisions1983–19940 recalls

FDA records 13 decisions for Mast Immunosystems (Mountain View, CA) from 1983 to 1994: 13 510(k) clearances. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and DGC (Ige, Antigen, Antiserum, Control). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Mast Immunosystems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mast Immunosystems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mast Immunosystems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mast Immunosystems’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

Other applicant names beginning “Mast”

FDA records each applicant name separately; these may or may not be the same firm.