Company ยท US
Ino Therapeutics
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2013. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2013 | K130605 | INOMAX DSIR (DELIVERY SYSTEM) Ino Therapeutics | MRN |
| Nov 7, 2012 | K122689 | INOBLENDER Ino Therapeutics | MRO |
| Sep 24, 2012 | K121021 | INOMAX DS (DELIVERY SYSTEM) Ino Therapeutics | MRN |
| Jun 24, 2011 | K110344 | INOMAX DSIR (DELIVERY SYSTEM) Ino Therapeutics | MRN |
| Apr 15, 2010 | K093922 | INOMAX DS Ino Therapeutics | MRN |
| Mar 10, 2010 | K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 Ino Therapeutics, LLC | MRN |
| Jun 18, 2009 | K090958 | INOMAX DS (DELIVERY SYSTEM) Ino Therapeutics, LLC | MNR |
| Aug 28, 2008 | K081691 | INOMAX DS (DELIVERY SYSTEM) Ino Therapeutics, LLC | MRN |
| Aug 6, 2008 | K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 Ino Therapeutics | MRN |
| Oct 3, 2007 | K071516 | INOMAX DS Ino Therapeutics, LLC | MRN |
| Apr 27, 2007 | K070867 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 Ino Therapeutics, LLC | MRN |
| Dec 14, 2006 | K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 Ino Therapeutics | MRN |
| Nov 4, 2005 | K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 Ino Therapeutics | MRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Ino Therapeutics INOmax DS (Delivery System) Model 10003 & 10007.
The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in Terminated |
MRN | K061901 |
| Aug 25, 2006 | INO Therapeutics, Inc. INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000 Terminated |
MRN | K000186 |