Data / Medical devices / Ireland / Mallinckrodt Medical
Mallinckrodt Medical: FDA-registered device maker in ATHLONE Westmeath, Ireland, 15 510(k) clearances
Mallinckrodt Medical is registered with the FDA (registration 8020889) in ATHLONE Westmeath, Ireland. It lists 7 device types. The FDA files 15 510(k) clearances under its listings, the newest dated December 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020889
- FEI number
- 3003382061
- Address
- Cornamaddy, ATHLONE Westmeath, Ireland, --
- Owner or operator
- Covidien llc (1282497)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
- First device listed
- January 30, 2008
- Registered through
- 2026
- Brand names listed
- BronchoCath, BronchoCath with CPAP, Cragg-McNamara Valved Infusion Catheter, Infusion Catheter, LaserFlex, STYLET, TRACHEAL TUBE, Safety Flex, SealGuard Evac Tracheal Tubes and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Contract manufacturer, Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Manufacturer | accessdata.fda.gov |
| Tube Tracheostomy And Tube Cuff | JOH | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Bronchial (W/Wo Connector) | BTS | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheostomy (W/Wo Connector) | BTO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 29, 2025 | K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | JOH | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 6, 2025 | K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | BTR | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 25, 2025 | K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | BTR | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| June 1, 2020 | K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 14, 2015 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 2, 2008 | K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| June 16, 2005 | K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| October 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| October 14, 1994 | K940634 | MICRO THERAPEUTICS INFUSION CATHETER | FOZ | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| August 22, 1991 | K912240 | CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM | BYE | Substantially Equivalent | Mallinckrodt Anesthesia Products | accessdata.fda.gov |
| November 6, 1987 | K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| April 21, 1987 | K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| August 1, 1986 | K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| April 13, 1979 | K790575 | TUBE, ARMORED TRACHEAL | BTR | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| August 4, 1977 | K771219 | BRONCHO-CATH | BTS | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Stylet, Tracheal Tube
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Tube, Tracheostomy (W/Wo Connector)
- All makers of Tube, Bronchial (W/Wo Connector)
Updated December 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.