# Mallinckrodt Medical Tpi, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 4 (1993–1995): 4 510(k) clearances
- Product codes: BTO (2), JOH (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Tracoe Medical GmbH: 1 (https://510kreport.com/company/tracoe-medical)

## Its most-cited devices
- K945406: SSV Phonate (TM) Shiley Speaking Valve (1995), cited by 1

## Recent decisions
- K945407: Ssvo Phonate (TM) Shiley Speaking Valve with Oxygen Port (Feb 27, 1995)
- K945406: SSV Phonate (TM) Shiley Speaking Valve (Feb 27, 1995)
- K936224: Reusable Cannula Tracheostomy Tubes, Modified Heads (Aug 30, 1994)
- K930895: Shiley Fenestrated Reusable Inner Cannula, Modif (Jul 2, 1993)

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