510(k) Report

FDA applicant

Huestis Machine Corp.

Bristol, RI7 decisions1980–20180 recalls

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, last Nov 3, 2026

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

How often FDA has decided Huestis Machine Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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.

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Other applicant names beginning “Huestis”

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