FDA applicant

Cala Health, Inc.

San Mateo, CA7 decisions2018–20260 recalls

FDA records 7 decisions for Cala Health, Inc. (San Mateo, CA) from 2018 to 2026: 6 510(k) clearances and 1 De Novo grant. All are in product code QBC (External Upper Limb Tremor Stimulator). Its devices cite 9 predicates, 9 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 Cala Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Cala Health, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cala Health, 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 “Cala”

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

Cala Diagnostics 12

Cala Health, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cala”