510(k) Report

FDA applicant

San Cheong Co., Ltd.

Santa Fe Springs, CA1 decision2009–20090 recalls

FDA records 1 decision for San Cheong Co., Ltd. (Santa Fe Springs, CA) in 2009: 1 510(k) clearance. All are in product code CAN (Regulator, Pressure, Gas Cylinder). Its devices cite 3 predicates, 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 San Cheong Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — San Cheong Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like San Cheong Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CANRegulator, Pressure, Gas Cylinder1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009

The one decision as San Cheong Co., Ltd. →