Data / Medical devices / United States / Mallinckrodt Hospital Products Inc.
Mallinckrodt Hospital Products Inc.: FDA-registered device maker in Bridgewater, NJ, United States, 3 510(k) clearances
Mallinckrodt Hospital Products Inc. is registered with the FDA (registration 3014527933) in Bridgewater, NJ, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 3, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014527933
- FEI number
- 3014074925
- Address
- 440 Route 22 East Suite 302, Bridgewater, NJ, United States, 08807
- Owner or operator
- Mallinckrodt Hospital Products Inc. (10057439)
- Roles
- Complaint file establishment
- First device listed
- April 5, 2018
- Registered through
- 2026
- Brand names listed
- Evolve Nitric Oxide Delivery System, INOcal Nitric Oxide Calibration Gas, INOcal Nitrogen Dioxide Calibration Gas, INOmax DSIR (Delivery System), INOmax DSIR Plus MRI (Delivery System)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Nitric Oxide | MRP | 2 | Complaint file establishment | accessdata.fda.gov |
| Analyzer, Nitrogen Dioxide | MRQ | 2 | Complaint file establishment | accessdata.fda.gov |
| Apparatus, Nitric Oxide Delivery | MRN | 2 | Complaint file establishment | accessdata.fda.gov |
| Apparatus, Nitric Oxide, Backup Delivery | MRO | 2 | Complaint file establishment | accessdata.fda.gov |
| Gas, Calibration (Specified Concentration) | BXK | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| January 3, 2025 | K242578 | EVOLVE Nitric Oxide Delivery System | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 23, 2022 | 90723 | Class II | Ongoing | INOmax DSIR -(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 constant concentration of nitric oxide (NO), as | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected w | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Nitric Oxide
- All makers of Apparatus, Nitric Oxide, Backup Delivery
- All makers of Analyzer, Nitrogen Dioxide
- All makers of Apparatus, Nitric Oxide Delivery
- All makers of Gas, Calibration (Specified Concentration)
Updated January 3, 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.