# Mallinckrodt Group, Inc.

- Location (FDA's records): Cincinnati, OH
- FDA decisions: 27 (1976–1995): 27 510(k) clearances
- Product codes: DXT (6), KPX (4), KPR (3), KQS (2), IXR (2), JAA (1), FYA (1), IZZ (1), FMW (1), KKX (1), IXA (1), LJH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 12 (0 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Mallinckrodt Inc., Liebel-Flarsheim Business: 4 (https://510kreport.com/company/mallinckrodt-liebel-flarsheim-business)
- Coeur, Inc.: 2 (https://510kreport.com/company/coeur)
- Ge Dec Medical Systems: 2 (https://510kreport.com/company/ge-dec-medical-systems)
- Nemoto Kyorindo Co., Ltd.: 1 (https://510kreport.com/company/nemoto-kyorindo)
- Pck Electronic Industry and Trade Co, Ltd.: 1 (https://510kreport.com/company/pck-electronic-industry-and-trade)
- Unimachs Corp.: 1 (https://510kreport.com/company/unimachs)
- Liebel-Flarsheim Company, LLC: 1 (https://510kreport.com/company/liebel-flarsheim)

## Its most-cited devices
- K912944: CT 8000 Digital Injection System (1992), cited by 6
- K943581: Hydradjust IV Urological Table (1995), cited by 3
- K860204: Angiomat 6000 (1986), cited by 2
- K904145: Hydra Vision Urological X-Ray System (1990), cited by 1

## Recent decisions
- K945053: LF CT Hig Pressure Catheters (May 19, 1995)
- K945140: Uro-Flo (Mar 8, 1995)
- K943581: Hydradjust IV Urological Table (Jan 4, 1995)
- K943122: Surgical Drapes (Sep 7, 1994)
- K934664: Hydragown (May 24, 1994)
- K920742: Hydrajust IV Urological Table (Apr 27, 1992)
- K912944: CT 8000 Digital Injection System (Feb 4, 1992)
- K913264: Hydraview 1000 Digital Image Process/Stor Device (Nov 1, 1991)

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