FDA applicant

Cosmed Srl

West Cadwell, NJ10 decisions1997–20200 recalls

FDA records 10 decisions for Cosmed Srl (West Cadwell, NJ) from 1997 to 2020: 10 510(k) clearances. Most are in product codes BTY (Calculator, Predicted Values, Pulmonary Function) and BZC (Calculator, Pulmonary Function Data). 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2020

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cosmed Srl by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cosmed Srl’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 “Cosmed”

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

Cosmed Nordic Aps 1

Cosmed Srl

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 “Cosmed”