510(k) Report

FDA applicant

American Health Care Systems, Inc.

Metairie, LA1 decision1997–19970 recalls

FDA records 1 decision for American Health Care Systems, Inc. (Metairie, LA) in 1997: 1 510(k) clearance. All are in product code FLD (Apparatus, Hemoperfusion, Sorbent). 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, gastroenterology and urology panel, where it files most

How often FDA has decided American Health Care Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Health Care Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Health Care Systems, 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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