# Mallinckrodt Manufacturing, LLC

- Location (FDA's records): Madison, WI
- FDA decisions: 4 (2020–2025): 4 510(k) clearances
- Product codes: MRN (4)
- 510(k) review time since 2016: median 436 days, against 566 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ino Therapeutics/Ikaria: 2 (https://510kreport.com/company/ino-therapeutics-ikaria)
- Malinckrodt Manufacturing, LLC: 1 (https://510kreport.com/company/malinckrodt-manufacturing)

## Firms that cite its devices most
- Malinckrodt Manufacturing, LLC: 1 (https://510kreport.com/company/malinckrodt-manufacturing)
- Airgas Therapeutics, LLC: 1 (https://510kreport.com/company/airgas-therapeutics)

## Its most-cited devices
- K200389: INOmax DSIR Plus (2020), cited by 2
- K222930: Evolve Nitric Oxide Delivery System (2023), cited by 1

## Recent decisions
- K242578: EVOLVE Nitric Oxide Delivery System (Jan 3, 2025)
- K222930: Evolve Nitric Oxide Delivery System (Dec 6, 2023)
- K211153: Inomax DSIR (Apr 20, 2023)
- K200389: INOmax DSIR Plus (Jun 17, 2020)

Source page: https://510kreport.com/company/mallinckrodt-manufacturing