510(k) Report

FDA applicant

Matria Healthcare, Inc.

Marietta3 decisions1990–19950 recalls

FDA records 3 decisions for Matria Healthcare, Inc. (Marietta) from 1990 to 1995: 3 original PMA approvals. Most are in product codes LQK (Home Uterine Activity Monitor) and HFM (Monitor, Uterine Contraction, External (For…). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Matria Healthcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Matria Healthcare, 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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