510(k) Report

FDA applicant

International Business Strategies

Mount Pleasant, SC2 decisions2000–20070 recalls

FDA records 2 decisions for International Business Strategies (Mount Pleasant, SC) from 2000 to 2007: 2 510(k) clearances. Most are in product codes DQA (Oximeter) and CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). 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, cardiovascular panel, where it files most

How often FDA has decided International Business Strategies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 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 — International Business Strategies 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?

  • DQAOximeter1decision
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase1decision

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?

  • K062149SP02 Sensor FS and PS 'Silc-Touch' Series; SP02 Sensor FC, FP and Y SeriesInternational Business Strategies · 2007
  • K002384M-XX Oxygen SensorsInternational Business Strategies · 2000

All 2 as International Business Strategies →