510(k) Report

FDA applicant

Longfian Scitech Co., Ltd.

Baoding, CN3 decisions2014–20251 recall

FDA records 3 decisions for Longfian Scitech Co., Ltd. (Baoding, CN) from 2014 to 2025: 3 510(k) clearances. All are in product code CAW (Generator, Oxygen, Portable). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Longfian Scitech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12022: 12025: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2014high 1 (2026) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Longfian Scitech Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Longfian Scitech 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, Portable3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K131968Longfian Oxygen ConcentratorLongfian Scitech Co., Ltd. · 20142cite it

What has FDA decided for it lately?

  • K243833Portable oxygen concentrator (JAY-1000P)Longfian Scitech Co., Ltd. · 2025
  • K213210Oxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd. · 20221 recall
  • K131968Longfian Oxygen ConcentratorLongfian Scitech Co., Ltd. · 2014

All 3 as Longfian Scitech Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K213210React Health PHOENIX 5L Oxygen ConcentratorFeb 4, 2026Class II