FDA applicant

Cranial Technologies, Inc.

Tempe, AZ4 decisions1998–20250 recalls

FDA records 4 decisions for Cranial Technologies, Inc. (Tempe, AZ) from 1998 to 2025: 3 510(k) clearances and 1 De Novo grant. Most are in product codes MVA (Orthosis, Cranial) and OAN (Orthosis, Cranial, Laser Scan). 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, neurology panel, where it files most

How often FDA has decided Cranial Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 1 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cranial Technologies, Inc.’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 “Cranial”

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

Cranial Solutions 1

Cranial Technologies, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cranial”