FDA applicant

Etiometry, Inc.

Boston, MA11 decisions2015–20260 recalls

FDA records 11 decisions for Etiometry, Inc. (Boston, MA) from 2015 to 2026: 11 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and PPW (Adjunctive Cardiovascular Status Indicator). Since 2016 its 510(k)s took a median of 205 days from receipt to decision, against 205 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 12 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2015high 2 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Etiometry, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Etiometry, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?