FDA applicant

Cranial Solutions

Pompton Lakes, NJ1 decision2007–20070 recalls

FDA records 1 decision for Cranial Solutions (Pompton Lakes, NJ) in 2007: 1 510(k) clearance. All are in product code MVA (Orthosis, Cranial). 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 Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cranial Solutions’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 “Cranial”

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

Cranial Technologies, Inc. 4

Cranial Solutions

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Cranial”