510(k) Report

FDA applicant

Dima Italia Srl

Boulder, CO4 decisions2008–20140 recalls

FDA records 4 decisions for Dima Italia Srl (Boulder, CO) from 2008 to 2014: 4 510(k) clearances. Most are in product codes NHJ (Device, Positive Pressure Breathing…) and BYT (Ventilator, External Body, Negative Pressure…). Its devices cite 10 predicates, 2 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 Dima Italia Srl’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2008: 22014: 2
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Dima Italia Srl by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NHJDevice, Positive Pressure Breathing, Intermittent3decisions
  • BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)1decision

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K072292Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl · 20085cite it
  • K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 20141cites it

What has FDA decided for it lately?

  • K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 2014
  • K140605Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug PercDima Italia Srl · 2014
  • K072290Pegaso V, Negavent Respirator, Model: DA-3 PlusDima Italia Srl · 2008
  • K072292Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl · 2008

All 4 as Dima Italia Srl →