# Ino Therapeutics/Ikaria

- Location (FDA's records): Madison, WI
- FDA decisions: 2 (2013–2015): 2 510(k) clearances
- Product codes: MRN (2)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ino Therapeutics: 11 (https://510kreport.com/company/ino-therapeutics)
- Ino Therapeutics, LLC/Dba Ikaria: 2 (https://510kreport.com/company/ino-therapeutics-dba-ikaria)

## Firms that cite its devices most
- Mallinckrodt Manufacturing, LLC: 2 (https://510kreport.com/company/mallinckrodt-manufacturing)

## Its most-cited devices
- K131686: Inomax Dsir (Delivery System) (2013), cited by 3

## Recent decisions
- K143213: INOmax DSIR Plus MRI (Jul 10, 2015)
- K131686: Inomax Dsir (Delivery System) (Nov 29, 2013)

Source page: https://510kreport.com/company/ino-therapeutics-ikaria