Company ยท US
INO Therapeutics (dba Ikaria)
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2012. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MRN | Apparatus, Nitric Oxide Delivery | 7 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2018 | INO therapeutics LLC/dba ikaria Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System.
Product Usage;
Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the deliver Terminated |
MRN | K131686 |
| Nov 21, 2016 | INO Therapeutics (dba Ikaria) Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation).
The INOmax DSIR uses a dual-channel design to ensure the safe delivery of Terminated |
MRN | K131686 |
| Feb 27, 2015 | INO Therapeutics (dba Ikaria) Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. Terminated |
MRN | K093922 |
| Dec 12, 2014 | INO Therapeutics (dba Ikaria) INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO Terminated |
MRN | K131686 |
| May 2, 2014 | INO Therapeutics (dba Ikaria) INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous mo Terminated |
MRN | K131686 |