# Mallinckrodt Inc., Liebel-Flarsheim Business

- Location (FDA's records): Cincinnati, OH
- FDA decisions: 8 (1997–2009): 8 510(k) clearances
- Product codes: DXT (7), IZQ (1)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 13 (4 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mallinckrodt Group, Inc.: 4 (https://510kreport.com/company/mallinckrodt-group)
- Medrad, Inc.: 1 (https://510kreport.com/company/medrad)

## Firms that cite its devices most
- Nemoto Kyorindo Co., Ltd.: 3 (https://510kreport.com/company/nemoto-kyorindo)
- Coeur, Inc.: 3 (https://510kreport.com/company/coeur)
- Liebel-Flarsheim Company, LLC: 1 (https://510kreport.com/company/liebel-flarsheim)
- Medrad, Inc.: 1 (https://510kreport.com/company/medrad)
- Benlan, Inc.: 1 (https://510kreport.com/company/benlan)

## Its most-cited devices
- K984088: Optistar MR Injector System (1999), cited by 5
- K963071: Angiomat Illumena (1997), cited by 3
- K063503: Optivantage DH Injector System with Enhanced Communication (2007), cited by 2
- K042744: Optiv Antage DH Power Injection System (2004), cited by 2
- K031339: Optibolus (2003), cited by 1

## Recent decisions
- K082212: Syringe with Handi-Fil (Jan 22, 2009)
- K073592: Optistar Elite Injection System (May 7, 2008)
- K063503: Optivantage DH Injector System with Enhanced Communication (Apr 27, 2007)
- K042744: Optiv Antage DH Power Injection System (Nov 30, 2004)
- K031339: Optibolus (Jul 11, 2003)
- K022116: Elph Injection System (Jul 26, 2002)
- K984088: Optistar MR Injector System (Dec 6, 1999)
- K963071: Angiomat Illumena (Sep 23, 1997)

Source page: https://510kreport.com/company/mallinckrodt-liebel-flarsheim-business