Ino Therapeutics
Country not established
- Devices
- 13
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Ino Therapeutics makes
Ino Therapeutics manufactures drug delivery systems and blending devices for inhaled therapies, including the INOMAX DS and INOBLENDER. These products are designed to administer and prepare inhaled medications, such as hypertonic saline solutions, for respiratory treatment.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are regulated under U.S. jurisdiction and are intended for use in respiratory care applications.
Catalogue
Search and filter all 13 devicesFDA recalls
FDA recall records list 2 recalls initiated by Ino Therapeutics, the earliest on 2006-06-29 and the most recent on 2010-11-30. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 30 Nov 2010 Z-0583-2012 Unclassified (pre-2012) Terminated Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.
2006
- 29 Jun 2006 Z-1410-06 Unclassified (pre-2012) Terminated The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
Frequently asked questions
How many devices does Ino Therapeutics have in the registry?
The registry currently lists 13 devices for Ino Therapeutics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ino Therapeutics's devices?
Among its 13 most recently registered devices, Ino Therapeutics has devices listed in FDA 510(k) (13 devices).
What risk classes do Ino Therapeutics's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Ino Therapeutics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ino Therapeutics?
FDA recall records list 2 recalls initiated by Ino Therapeutics, the most recent initiated on 30 Nov 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ino Therapeutics in the registry?
The most recently registered devices listed for Ino Therapeutics include INOMAX DS (DELIVERY SYSTEM), INOMAX DS (DELIVERY SYSTEM), MODEL 10003, INOMAX DSIR (DELIVERY SYSTEM) and INOMAX DS.