510(k) Report

FDA applicant

Mallinckrodt Group, Inc.

Cincinnati, OH27 decisions1976–19958 recalls

FDA records 27 decisions for Mallinckrodt Group, Inc. (Cincinnati, OH) from 1976 to 1995: 27 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and KPX (Changer, Radiographic Film/Cassette). 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Mallinckrodt Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mallinckrodt Group, Inc. since 2007.

Recalls per year

1in 2017

2008: 12010: 22011: 22012: 12013: 12017: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mallinckrodt Group, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXTInjector And Syringe, Angiographic6decisions
  • KPXChanger, Radiographic Film/Cassette4decisions
  • KPRSystem, X-Ray, Stationary3decisions
  • KQSTable, Cystometric, Non-Electric And Accessories2decisions
  • IXRTable, Radiographic, Tilting2decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

Also: FYA (1), IZZ (1), FMW (1), KKX (1), IXA (1), LJH (1).

Who builds on its devices?

Later devices cite its devices 12 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K912944CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 19926cite it
  • K943581Hydradjust IV Urological TableMallinckrodt Group, Inc. · 19953cite it
  • K860204Angiomat 6000Mallinckrodt Group, Inc. · 19862cite it
  • K904145Hydra Vision Urological X-Ray SystemMallinckrodt Group, Inc. · 19901cites it

What has FDA decided for it lately?

  • K945053LF CT Hig Pressure CathetersMallinckrodt Group, Inc. · 1995
  • K945140Uro-FloMallinckrodt Group, Inc. · 1995
  • K943581Hydradjust IV Urological TableMallinckrodt Group, Inc. · 19953 recalls
  • K943122Surgical DrapesMallinckrodt Group, Inc. · 1994
  • K934664HydragownMallinckrodt Group, Inc. · 1994
  • K920742Hydrajust IV Urological TableMallinckrodt Group, Inc. · 19921 recall
  • K912944CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 19921 recall
  • K913264Hydraview 1000 Digital Image Process/Stor DeviceMallinckrodt Group, Inc. · 1991

All 27 as Mallinckrodt Group, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K943581Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems…Feb 27, 2017Class II
  • K943581Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The…Apr 25, 2013Class II
  • K882329Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch…Feb 10, 2012
  • K781334Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt…Dec 20, 2011
  • K781334Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL…Oct 11, 2011
  • K920742Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n…Jun 14, 2010

Other applicant names beginning “Mallinckrodt”

FDA records each applicant name separately; these may or may not be the same firm.

Mallinckrodt Critical Care 92Mallinckrodt Medical 43Mallinckrodt Inc., Liebel-Flarsheim Business 8Mallinckrodt Developpement France 7Mallinckrodt Manufacturing, LLC 4Mallinckrodt Medical Tpi, Inc. 4Mallinckrodt Anesthesia Products 3Mallinckrodt, Inc. 2Mallinckrodt Dar S.R.L. 2Mallinckrodt Sensor Systems, Inc. 2