510(k) Report

FDA applicant

Fim Medical

Deer Field, IL4 decisions2002–20160 recalls

FDA records 4 decisions for Fim Medical (Deer Field, IL) from 2002 to 2016: 4 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase). Its devices cite 3 predicates, 1 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 Fim Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fim Medical 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?

  • BZGSpirometer, Diagnostic3decisions
  • CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase1decision

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 3 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.

  • K080278Tabataba CotesterFim Medical · 20082cite it
  • K010761SPL-50 SpirolyserFim Medical · 20021cites it

What has FDA decided for it lately?

  • K161676Q13 Spirolyser®Fim Medical · 2016
  • K080278Tabataba CotesterFim Medical · 2008
  • K050424Ergofilter Spi Accessory to Spirolyser SPL-50Fim Medical · 2005
  • K010761SPL-50 SpirolyserFim Medical · 2002

All 4 as Fim Medical →