FDA applicant

Molekule, Inc.

San Francisco, CA3 decisions2020–20210 recalls

FDA records 3 decisions for Molekule, Inc. (San Francisco, CA) from 2020 to 2021: 3 510(k) clearances. All are in product code FRA (Purifier, Air, Ultraviolet, Medical). Its devices cite 3 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, general hospital panel, where it files most

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

FDA decisions per year

2in 2021

2020high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Molekule, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Molekule, 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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Molekule, 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?