510(k) Report

FDA applicant

Nanma Mfg Co., Ltd.

Crofton, MD9 decisions2000–20040 recalls

FDA records 9 decisions for Nanma Mfg Co., Ltd. (Crofton, MD) from 2000 to 2004: 9 510(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 Nanma Mfg Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nanma Mfg Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nanma Mfg Co., Ltd.’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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