FDA applicant

Proteus Digital Health, Inc.

Redwood City, CA4 decisions2013–20150 recalls

FDA records 4 decisions for Proteus Digital Health, Inc. (Redwood City, CA) from 2013 to 2015: 4 510(k) clearances. All are in product code OZW (Ingestible Event Marker). Its devices cite 5 predicates, 3 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 Proteus Digital Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013high 2 (2013) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Proteus Digital Health, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Proteus Digital 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 “Proteus”

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

Proteus Biomedical, Inc. 2

Proteus Digital Health, 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?

Other applicant names beginning “Proteus”