510(k) Report

FDA applicant

Guan Hong Enterprise Co., Ltd.

Flagstaff, AZ1 decision2004–20040 recalls

FDA records 1 decision for Guan Hong Enterprise Co., Ltd. (Flagstaff, AZ) in 2004: 1 510(k) clearance. All are in product code CAF (Nebulizer (Direct Patient Interface)). 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, anesthesiology panel, where it files most

How often FDA has decided Guan Hong Enterprise Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Guan Hong Enterprise Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Guan Hong Enterprise 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?

  • CAFNebulizer (Direct Patient Interface)1decision

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?

  • K041079Guan Hong Ultrasonic Nebulizer, Model DR-103/AC-103Guan Hong Enterprise Co., Ltd. · 2004

The one decision as Guan Hong Enterprise Co., Ltd. →