Data / Medical devices / United States / Ivwatch, LLC
Ivwatch, LLC: FDA-registered device maker in Newport News, VA, United States, 6 510(k) clearances
Ivwatch, LLC is registered with the FDA (registration 3011490091) in Newport News, VA, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011490091
- Address
- 700 Tech Center Parkway, Suite 300, Newport News, VA, United States, 23606
- Owner or operator
- ivWatch, LLC (10048801)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 3, 2015
- Registered through
- 2026
- Brand names listed
- ivWatch Model 400
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Intravenous (Piv) Infiltration Monitor | PMS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 15, 2024 | K233881 | ivWatch® Model 400 | PMS | Substantially Equivalent | Ivwatch, LLC | accessdata.fda.gov |
| August 24, 2022 | K222212 | ivWatch Model 400 | PMS | Substantially Equivalent | Ivwatch, LLC | accessdata.fda.gov |
| July 2, 2020 | K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | PMS | Substantially Equivalent | Ivwatch, LLC | accessdata.fda.gov |
| December 22, 2016 | K162478 | ivWatch | PMS | Substantially Equivalent | Ivwatch, LLC | accessdata.fda.gov |
| February 11, 2016 | K153605 | ivWatch Model 400 | PMS | Substantially Equivalent | Ivwatch, LLC | accessdata.fda.gov |
| February 13, 2015 | K142374 | ivWatch Model 400 | MRZ | Substantially Equivalent | Ivwatch, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 15, 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.