INOMAX DS— 510(k) K093922

Name: FDA 510(k) clearance K093922
Creator: U.S. Food and Drug Administration
Published: 2010-04-15

Substantially Equivalent

Ino Therapeutics

FDA 510(k) clearance K093922 for INOMAX DS, Substantially Equivalent on 2010-04-15. Applicant: Ino Therapeutics. Device class: 2.

Clearance details

Applicant: Ino Therapeutics
Product code: Code MRN
Device class: Class 2
Regulation: 21 CFR 868.5165
Advisory panel: Anesthesiology
Date received: 2009-12-22
Decision date: 2010-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K093922

K-number listed on FDA's recall record

Z-1223-2015 — Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.Class II·Terminated·INO Therapeutics (dba Ikaria)·20150114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093922.

Data sourced from openFDA. This site is unofficial and independent of the FDA.