510(k) Report

FDA applicant

Mir Medical Intl. Research Srl

Roma, IT10 decisions1998–20130 recalls

FDA records 10 decisions for Mir Medical Intl. Research Srl (Roma, IT) from 1998 to 2013: 10 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and DQA (Oximeter). Its devices cite 12 predicates, 9 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 Mir Medical Intl. Research Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12008: 12009: 12012: 12013: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mir Medical Intl. Research Srl 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, Diagnostic9decisions
  • DQAOximeter1decision

Whose devices does it build on?

Its devices cite 12 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 9 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.

  • K072979Spirobank GMir Medical Intl. Research Srl · 20077cite it
  • K061712Spirobank IIMir Medical Intl. Research Srl · 20063cite it
  • K043528SpirotelMir Medical Intl. Research Srl · 20052cite it
  • K983909Mir Spirobank SpirometerMir Medical Intl. Research Srl · 19982cite it
  • K052140Spirolab, Spirolab IIMir Medical Intl. Research Srl · 20062cite it
  • K082766Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 20081cites it

What has FDA decided for it lately?

  • K130784SpirotelMir Medical Intl. Research Srl · 2013
  • K122384MinispirMir Medical Intl. Research Srl · 2012
  • K081033MiroxiMir Medical Intl. Research Srl · 2009
  • K082766Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008
  • K072979Spirobank GMir Medical Intl. Research Srl · 2007
  • K061875Minispir; Spirolab IiiMir Medical Intl. Research Srl · 2006
  • K061712Spirobank IIMir Medical Intl. Research Srl · 2006
  • K052140Spirolab, Spirolab IIMir Medical Intl. Research Srl · 2006

All 10 as Mir Medical Intl. Research Srl →