FDA applicant
Huestis Machine Corp.
FDA records 7 decisions for Huestis Machine Corp. (Bristol, RI) from 1980 to 2018: 7 510(k) clearances. Most are in product codes IXI (Block, Beam-Shaping, Radiation Therapy) and IYE (Accelerator, Linear, Medical). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Huestis Machine Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Huestis Machine Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Huestis Machine 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 “Huestis”
FDA records each applicant name separately; these may or may not be the same firm.