Data / Medical devices / United States / Mallinckrodt Manufacturing LLC
Mallinckrodt Manufacturing LLC: FDA-registered device maker in Madison, WI, United States, 20 510(k) clearances
Mallinckrodt Manufacturing LLC is registered with the FDA (registration 3004531588) in Madison, WI, United States. It lists 9 device types. The FDA files 20 510(k) clearances under its listings, the newest dated December 6, 2023. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004531588
- Address
- 6603 Femrite Dr, Madison, WI, United States, 53718
- Owner or operator
- Mallinckrodt Hospital Products IP Limited (10050702)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer
- First device listed
- December 17, 2015
- Registered through
- 2026
- Brand names listed
- 15 M Adapter (fits 4.5 mm ID Tubing), 15M Adapter (fits 8 mm ID Tubing), Adapter , 22 mm OD X 10 mm OD, Adapter , 22F X 15M, Adapter , 22M/15F X 22M/15F, Adapter , Cuff, 22 mm ID X 22 mm ID, Adapter , Gas Sample Tee, Adapter, 90 Degree Sample Port and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Nitric Oxide | MRP | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Analyzer, Nitrogen Dioxide | MRQ | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Apparatus, Nitric Oxide Delivery | MRN | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Apparatus, Nitric Oxide, Backup Delivery | MRO | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer | accessdata.fda.gov |
| System, Rebreathing, Radionuclide | IYT | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Contract manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer, Remanufacturer | 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 6, 2023 | K222930 | Evolve Nitric Oxide Delivery System | MRN | Substantially Equivalent | Mallinckrodt Manufacturing, LLC | accessdata.fda.gov |
| April 20, 2023 | K211153 | Inomax DSIR | MRN | Substantially Equivalent | Mallinckrodt Manufacturing, LLC | accessdata.fda.gov |
| July 10, 2015 | K143213 | INOmax DSIR Plus MRI | MRN | Substantially Equivalent | Ino Therapeutics/Ikaria | accessdata.fda.gov |
| November 29, 2013 | K131686 | INOMAX DSIR (DELIVERY SYSTEM) | MRN | Substantially Equivalent | Ino Therapeutics/Ikaria | accessdata.fda.gov |
| May 2, 2013 | K130605 | INOMAX DSIR (DELIVERY SYSTEM) | MRN | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| November 7, 2012 | K122689 | INOBLENDER | MRO | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| September 24, 2012 | K121021 | INOMAX DS (DELIVERY SYSTEM) | MRN | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| February 29, 2012 | K113272 | INOMAX DS(DELIVERY SYSTEMS | MRN | Substantially Equivalent | Ino Therapeutics, LLC/Dba Ikaria | accessdata.fda.gov |
| June 24, 2011 | K110344 | INOMAX DSIR (DELIVERY SYSTEM) | MRN | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| June 23, 2011 | K110635 | INOMAX DS(IR) (DELIVERY SYSTEM) | MRN | Substantially Equivalent | Ino Therapeutics, LLC/Dba Ikaria | accessdata.fda.gov |
| April 15, 2010 | K093922 | INOMAX DS | MRN | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| March 10, 2010 | K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | Ino Therapeutics, LLC | accessdata.fda.gov |
| June 18, 2009 | K090958 | INOMAX DS (DELIVERY SYSTEM) | MNR | Substantially Equivalent | Ino Therapeutics, LLC | accessdata.fda.gov |
| August 28, 2008 | K081691 | INOMAX DS (DELIVERY SYSTEM) | MRN | Substantially Equivalent | Ino Therapeutics, LLC | accessdata.fda.gov |
| August 6, 2008 | K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| October 3, 2007 | K071516 | INOMAX DS | MRN | Substantially Equivalent | Ino Therapeutics, LLC | accessdata.fda.gov |
| April 27, 2007 | K070867 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | Ino Therapeutics, LLC | accessdata.fda.gov |
| December 14, 2006 | K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| November 4, 2005 | K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 | MRO | Substantially Equivalent | Ino Therapeutics | accessdata.fda.gov |
| February 10, 2000 | K000186 | DATEX-OHMEDA INOVENT DELIVERY SYSTEM | MRN | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 8, 2023 | 92799 | Class I | Ongoing | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators. | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. | accessdata.fda.gov |
| November 21, 2016 | 75878 | Class II | Terminated | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first chann | Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device. | accessdata.fda.gov |
| January 14, 2015 | 70395 | Class II | Terminated | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. | Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted. | accessdata.fda.gov |
| October 17, 2014 | 69635 | Class II | Terminated | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive | An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board. | accessdata.fda.gov |
| March 27, 2014 | 67947 | Class II | Terminated | INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired | An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/ | accessdata.fda.gov |
| November 30, 2010 | 60258 | Not yet classified | Terminated | INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a | Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Nitric Oxide Delivery
- All makers of Analyzer, Nitrogen Dioxide
- All makers of Analyzer, Nitric Oxide
- All makers of Ventilatory Effort Recorder
- All makers of Apparatus, Nitric Oxide, Backup Delivery
- All makers of Tubing, Pressure And Accessories
Updated December 6, 2023. 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.