510(k) Report

FDA applicant

Acorn Medical Products

Palo Alto, CA1 decision1987–19870 recalls

FDA records 1 decision for Acorn Medical Products (Palo Alto, CA) in 1987: 1 510(k) clearance. All are in product code KOD (Catheter, Urological). 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 Acorn Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Acorn Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Acorn”

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