# Mallinckrodt, Inc.

- Location (FDA's records): St. Louis, MO
- FDA decisions: 2 (2000–2001): 2 510(k) clearances
- Product codes: MNT (1), JOH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Innomed Technologies: 1 (https://510kreport.com/company/innomed-technologies)
- Breas Medical AB: 1 (https://510kreport.com/company/breas-medical)
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)
- Mallinckrodt Medical: 1 (https://510kreport.com/company/mallinckrodt-medical)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K003075: Knightstar 330 Ventilator (2001), cited by 3
- K003315: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula (2000), cited by 2

## Recent decisions
- K003075: Knightstar 330 Ventilator (Dec 11, 2001)
- K003315: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula (Nov 8, 2000)

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