Data / Medical devices / United States / Hill-Rom Manufacturing, Inc.
Hill-Rom Manufacturing, Inc.: FDA-registered device maker in Saint Paul, MN, United States, 10 510(k) clearances
Hill-Rom Manufacturing, Inc. is registered with the FDA (registration 2183816) in Saint Paul, MN, United States. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 22, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183816
- Address
- 1020 County Road F W, Saint Paul, MN, United States, 55126
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 10, 2022
- Registered through
- 2026
- Brand names listed
- Maximus System, MetaNeb, Metaneb, Metaneb 4, Monarch Airway Clearance System, Optimus, Synclara Cough System, The Vest APX System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Percussor, Powered-Electric | BYI | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 22, 2024 | K233441 | The Vest APX System (PVAPX1) | BYI | Substantially Equivalent | Baxter Healthcare Corportation | accessdata.fda.gov |
| May 26, 2020 | K200988 | Maximus System | NHJ | Substantially Equivalent | Hill-Rom Services Pte, Ltd. | accessdata.fda.gov |
| February 14, 2020 | K192143 | Maximus System | NHJ | Substantially Equivalent | Hill-Rom Services Pte, Ltd. | accessdata.fda.gov |
| March 17, 2017 | K163378 | Monarch Airway Clearance System | BYI | Substantially Equivalent | Hill-Rom Services Pte, Ltd. | accessdata.fda.gov |
| March 17, 2016 | K151689 | MetaNeb 4 System | NHJ | Substantially Equivalent | Hill-Rom Services Pte, Ltd. | accessdata.fda.gov |
| May 7, 2015 | K142482 | The Vest Airway Clearance System | BYI | Substantially Equivalent | Hill-Rom Services Private Limited | accessdata.fda.gov |
| March 28, 2014 | K132988 | VITAL COUGH | NHJ | Substantially Equivalent | Lung Assist, Inc. | accessdata.fda.gov |
| April 25, 2013 | K124032 | METANEB | NHJ | Substantially Equivalent | Hill-Rom Services Pte, Ltd. | accessdata.fda.gov |
| December 1, 2005 | K051964 | POWERNEB | NHJ | Substantially Equivalent | Comedica , Inc. | accessdata.fda.gov |
| February 21, 2003 | K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | BYI | Substantially Equivalent | Advanced Respiratory | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 12, 2020 | 86756 | Class II | Terminated | Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport. | Under certain conditions, there is a risk for fire. | accessdata.fda.gov |
| September 15, 2017 | 78100 | Class II | Terminated | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarc | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device. | accessdata.fda.gov |
Compare with other makers
- All makers of Percussor, Powered-Electric
- All makers of Device, Positive Pressure Breathing, Intermittent
Updated March 22, 2024. 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.