510(k) Report

FDA applicant

Jan Medical, Inc.

Mountain View, CA2 decisions2016–20170 recalls

FDA records 2 decisions for Jan Medical, Inc. (Mountain View, CA) from 2016 to 2017: 1 510(k) clearance and 1 De Novo grant. All are in product code POP (Cranial Motion Measurement Device). Its devices cite 1 predicate, 1 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 Jan Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Jan Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jan Medical, Inc.’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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Which product codes does it file in?

  • POPCranial Motion Measurement Device2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN140040Nautilus BrainPulse 1000Jan Medical, Inc. · 20161cites it

What has FDA decided for it lately?

  • K170926BrainPulse 1100Jan Medical, Inc. · 2017
  • DEN140040Nautilus BrainPulse 1000Jan Medical, Inc. · 2016

All 2 as Jan Medical, Inc. →