Data / Medical devices / United States / Amsino Healthcare (USA) Inc.
Amsino Healthcare (USA) Inc.: FDA-registered device maker in Vernon Hills, IL, United States, 2 510(k) clearances
Amsino Healthcare (USA) Inc. is registered with the FDA (registration 1417519) in Vernon Hills, IL, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 14, 2021. 2 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
- 1417519
- Address
- 330 Corporate Woods Parkway, Vernon Hills, IL, United States, 60061
- Owner or operator
- Amsino Healthcare (USA) Inc. (10058949)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 27, 2018
- Registered through
- 2026
- Brand names listed
- Irrisept Antimicrobial Wound Lavage
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Contract manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 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 |
|---|---|---|---|---|---|---|
| April 14, 2021 | K201138 | AMSure® Single Use Saline Topical Solution | FRO | Substantially Equivalent | Amsino Medical, Inc. | accessdata.fda.gov |
| February 23, 1982 | K820227 | STER-O-DOSE | CAF | Substantially Equivalent | Inhalation Therapy Equipment, Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 5, 2017 | 81399 | Class II | Terminated | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | accessdata.fda.gov |
| September 5, 2017 | 81021 | Class I | Terminated | Portex 350 ml Sterile Water Humidifier w/5psi Adapt. | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Lavage, Jet
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
Updated April 14, 2021. 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.