510(k) Report

FDA applicant

Rowenta, Inc.

Medford, MA1 decision2003–20030 recalls

FDA records 1 decision for Rowenta, Inc. (Medford, MA) in 2003: 1 510(k) clearance. All are in product code MNW (Analyzer, Body Composition). 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 Rowenta, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rowenta, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rowenta, 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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