510(k) Report

FDA applicant

Walling Medical Equipment Co.

Mckinney, TX4 decisions1994–19980 recalls

FDA records 4 decisions for Walling Medical Equipment Co. (Mckinney, TX) from 1994 to 1998: 4 510(k) clearances. All are in product code LKY (Device, External Penile Rigidity). 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 Walling Medical Equipment Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Walling Medical Equipment Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Walling Medical Equipment Co.’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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