# Mallinckrodt Medical

- Location (FDA's records): St Louis, MO
- FDA decisions: 43 (1990–2008): 43 510(k) clearances
- Product codes: JOH (7), CAH (5), BYD (5), DQY (5), BTR (4), DQO (3), CAE (2), LIT (2), KPY (1), FRQ (1), DQX (1), BSY (1)
- Predicates its devices cite: 22 (3 its own); citations of its devices by later devices: 38 (3 its own)
- Recalls linked to its devices: 44 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shiley, Inc.: 15 (https://510kreport.com/company/shiley)
- Mallinckrodt Critical Care: 2 (https://510kreport.com/company/mallinckrodt-critical-care)
- Mallinckrodt Anesthesia Products: 1 (https://510kreport.com/company/mallinckrodt-anesthesia-products)
- Mallinckrodt, Inc.: 1 (https://510kreport.com/company/mallinckrodt)

## Firms that cite its devices most
- Covidien: 8 (https://510kreport.com/company/covidien)
- Engineered Medical Systems: 6 (https://510kreport.com/company/engineered-medical-systems)
- Munktell Filter AB: 3 (https://510kreport.com/company/munktell-filter)
- Vascular Solutions, Inc.: 3 (https://510kreport.com/company/vascular-solutions)
- Mallinckrodt Dar S.R.L.: 2 (https://510kreport.com/company/mallinckrodt-dar)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)
- Pediacath, Inc.: 1 (https://510kreport.com/company/pediacath)

## Its most-cited devices
- K965132: HI-LO Evac and Evac II Endotracheal Tubes (1997), cited by 7
- K943739: Softouch Diagnostic Intravascular Catheter (1994), cited by 5
- K962173: Shikey Tracheostomy Tubes and Accessories (1996), cited by 5
- K941381: Hygrobac,S Hygroboy and Hygrobaby (1994), cited by 4
- K941536: Barrierbac and Barrierbac S (1994), cited by 3
- K963732: Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula (1997), cited by 2

## Recent decisions
- K082520: Sealguard Evac Endotracheal and Endotracheal Tubes (Oct 2, 2008)
- K051416: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner Cannula (Jun 16, 2005)
- K972258: HI-Care Closed Suction System (Dec 29, 1997)
- K971267: Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension, Cuffed, Proximal Extension, Cuf (Sep 25, 1997)
- K963732: Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula (Jun 26, 1997)
- K955721: Cuffed Oropharyngeal Airway (Copa) (Mar 28, 1997)
- K965132: HI-LO Evac and Evac II Endotracheal Tubes (Mar 20, 1997)
- K962045: Anesthesia Breathing Circuit/Anesthesia Breathing Kit (Nov 26, 1996)

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