510(k) Report

FDA applicant

I.P.I. Medical Products

Chicago, IL1 decision2000–20000 recalls

FDA records 1 decision for I.P.I. Medical Products (Chicago, IL) in 2000: 1 510(k) clearance. All are in product code BTT (Humidifier, Respiratory Gas, (Direct Patient…). Its devices cite 6 predicates, 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, anesthesiology panel, where it files most

How often FDA has decided I.P.I. Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for I.P.I. Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — I.P.I. Medical Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like I.P.I. Medical Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K993282Ipi Humidifier ChamberI.P.I. Medical Products · 2000

The one decision as I.P.I. Medical Products →