510(k) Report

FDA applicant

Biosensors International-USA

Newport Beach, CA3 decisions2003–20220 recalls

FDA records 3 decisions for Biosensors International-USA (Newport Beach, CA) from 2003 to 2022: 2 510(k) clearances and 1 original PMA approval. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and NIQ (Coronary Drug-Eluting Stent). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biosensors International USA, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Biosensors International-USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12022: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biosensors International-USA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRSTransducer, Blood-Pressure, Extravascular1decision
  • NIQCoronary Drug-Eluting Stent1decision
  • DQOCatheter, Intravascular, Diagnostic1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K070710Accutrans Disposable Pressure Monitoring SystemBiosensors International-USA · 20072cite it

What has FDA decided for it lately?

  • P190020BioFreedom Drug Coated Coronary Stent SystemBiosensors International USA, Inc. · 2022
  • K070710Accutrans Disposable Pressure Monitoring SystemBiosensors International-USA · 2007
  • K022004Cardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model Ils-1Biosensors International-USA · 2003

All 2 as Biosensors International-USA →The one decision as Biosensors International USA, Inc. →

Other applicant names beginning “Biosensors”

FDA records each applicant name separately; these may or may not be the same firm.

Biosensors Intl. Pte., Ltd. 2Biosensors International Pte, Ltd. 1