510(k) Report

FDA applicant

3l Medical Products Co., Ltd.

Los Angeles, CA1 decision2005–20050 recalls

FDA records 1 decision for 3l Medical Products Co., Ltd. (Los Angeles, CA) in 2005: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided 3l Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 3l Medical Products Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3l Medical Products Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3l Medical Products 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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Which product codes does it file in?

  • KKXDrape, Surgical, Antimicrobial1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K0430153L Surgical Drapes3l Medical Products Co., Ltd. · 2005

The one decision as 3l Medical Products Co., Ltd. →