510(k) Report

FDA applicant

Aristo Medical Products, Inc.

Waukesha, WI4 decisions1993–19960 recalls

FDA records 4 decisions for Aristo Medical Products, Inc. (Waukesha, WI) from 1993 to 1996: 4 510(k) clearances. Most are in product codes DQA (Oximeter) and BZT (Stethoscope, Esophageal, With Electrical…). 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 Aristo Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aristo Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aristo Medical Products, 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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Other applicant names beginning “Aristo”

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