FDA applicant

Ash Medical Systems, Inc.

West Lafayette, IN3 decisions1986–19880 recalls

FDA records 3 decisions for Ash Medical Systems, Inc. (West Lafayette, IN) from 1986 to 1988: 3 510(k) clearances. All are in product code FKT (System, Dialysate Delivery, Sorbent Regenerated). 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 Ash Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ash Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ash Medical Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?