510(k) Report

FDA applicant

Zhejiang Longfei Industrial Co., Ltd.

Shanghai, CN1 decision2005–20050 recalls

FDA records 1 decision for Zhejiang Longfei Industrial Co., Ltd. (Shanghai, CN) in 2005: 1 510(k) clearance. All are in product code CAW (Generator, Oxygen, Portable). 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 Zhejiang Longfei Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zhejiang Longfei Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Zhejiang Longfei Industrial 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?

  • CAWGenerator, Oxygen, Portable1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033405Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 20051cites it

What has FDA decided for it lately?

  • K033405Longfei Lfy-I-5 Oxygen ConcentratorZhejiang Longfei Industrial Co., Ltd. · 2005

The one decision as Zhejiang Longfei Industrial Co., Ltd. →