FDA applicant

Glooko, Inc.

Palo Alto, CA5 decisions2012–20260 recalls

FDA records 5 decisions for Glooko, Inc. (Palo Alto, CA) from 2012 to 2026: 5 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and NDC (Calculator, Drug Dose). Its devices cite 5 predicates, 2 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2018

2012high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

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

Planning a device like Glooko, 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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Glooko, 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?