510(k) Report

FDA applicant

Mallinckrodt Medical

St Louis, MO43 decisions1990–200844 recalls

FDA records 43 decisions for Mallinckrodt Medical (St Louis, MO) from 1990 to 2008: 43 510(k) clearances. Most are in product codes JOH (Tube Tracheostomy And Tube Cuff) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 22 predicates, 3 of them its own earlier devices. 44 recalls are linked to its devices, 1 Class I.

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

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

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

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2021

2009: 12010: 322012: 1, 1 Class I2013: 22016: 22021: 4
2007high 32 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mallinckrodt Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JOHTube Tracheostomy And Tube Cuff7decisions
  • CAHFilter, Bacterial, Breathing-Circuit5decisions
  • BYDCondenser, Heat And Moisture (Artificial Nose)5decisions
  • DQYCatheter, Percutaneous5decisions
  • BTRTube, Tracheal (W/Wo Connector)4decisions
  • DQOCatheter, Intravascular, Diagnostic3decisions

Also: CAE (2), LIT (2), KPY (1), FRQ (1), DQX (1), BSY (1).

Whose devices does it build on?

Its devices cite 22 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 3 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.

  • K965132HI-LO Evac and Evac II Endotracheal TubesMallinckrodt Medical · 19977cite it
  • K943739Softouch Diagnostic Intravascular CatheterMallinckrodt Medical · 19945cite it
  • K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 19965cite it
  • K941381Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 19944cite it
  • K941536Barrierbac and Barrierbac SMallinckrodt Medical · 19943cite it
  • K963732Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner CannulaMallinckrodt Medical · 19972cite it

What has FDA decided for it lately?

  • K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 20082 recalls
  • K051416Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaMallinckrodt Medical · 2005
  • K972258HI-Care Closed Suction SystemMallinckrodt Medical · 1997
  • K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension, Cuffed, Proximal…Mallinckrodt Medical · 1997
  • K963732Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner CannulaMallinckrodt Medical · 19972 recalls
  • K955721Cuffed Oropharyngeal Airway (Copa)Mallinckrodt Medical · 1997
  • K965132HI-LO Evac and Evac II Endotracheal TubesMallinckrodt Medical · 1997
  • K962045Anesthesia Breathing Circuit/Anesthesia Breathing KitMallinckrodt Medical · 1996

All 43 as Mallinckrodt Medical →

What has been recalled?

44 recalls linked to its devices; the latest:

  • K941676Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single…Apr 29, 2021Class II
  • K941535Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated…Apr 29, 2021Class II
  • K941536Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product…Apr 29, 2021Class II
  • K941381HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for…Apr 29, 2021Class II
  • K082520Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular…Apr 4, 2016Class II
  • K082520Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175Apr 4, 2016Class II

Other applicant names beginning “Mallinckrodt”

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

Mallinckrodt Critical Care 92Mallinckrodt Group, Inc. 27Mallinckrodt 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