FDA applicant

Curvebeam, LLC

Warrington, PA6 decisions2012–20240 recalls

FDA records 6 decisions for Curvebeam, LLC (Warrington, PA) from 2012 to 2024: 6 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 4 of them its own earlier devices. 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, radiology panel, where it files most

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

FDA decisions per year

1in 2024

2012high 2 (2018) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Curvebeam, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Curvebeam, LLC’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 “Curvebeam”

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

Curvebeam AI / Curvebeam, LLC 1

Curvebeam, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Curvebeam”