510(k) Report

FDA applicant

Rimeco Products, Inc.

Oakwood Village, OH1 decision1994–19940 recalls

FDA records 1 decision for Rimeco Products, Inc. (Oakwood Village, OH) in 1994: 1 510(k) clearance. All are in product code FOC (Bag, Urine Collection, Newborn). 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 Rimeco Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rimeco Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rimeco 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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