12 premarket notifications (510(k)s) from applicants based in Virginia were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-08-10 | EM-TECH Solutions, Inc. | EM-TECH Passive Ultrasound Probe Strap ITX | Radiology | Chantilly, Virginia | K254143 |
| 2026-07-24 | Rivanna Medical, Inc. | Accuro 3S IYO | Radiology | Charlottesville, Virginia | K253452 |
| 2026-07-24 | Rivanna Medical, Inc. | Accuro® 3S Needle Guide Kit ITX | Radiology | Charlottesville, Virginia | K261014 |
| 2026-06-27 | Imagine Milling Technologies, LLC | MIST IC NHA | Dental | Chantilly, Virginia | K261122 |
| 2026-06-18 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | SmartSpectra Vital Signs Monitor 1.0 QME | Cardiovascular | Leesburg, Virginia | K254169 |
| 2026-04-20 | Luminoah | Luminoah FLOW Enteral Nutrition System LZH | General Hospital | Charlottesville, Virginia | K253558 |
| 2026-04-09 | Rivanna Medical, Inc. | Accuro XV IYO | Radiology | Charlottesville, Virginia | K254021 |
| 2026-03-17 | K2m, Inc. | Q Pedicle Instruments OLO | Neurology | Leesburg, Virginia | K260546 |
| 2026-02-17 | Liquet Medical, Inc. | Versus Catheter (VS110-9NB) QEY | Cardiovascular | Glen Allen, Virginia | K260149 |
| 2026-02-10 | K2m, Inc. | Vulcan Spinal System NKB | Orthopedic | Leesburg, Virginia | K253545 |
| 2026-02-06 | K2m, Inc. | Q Interbody Instruments OLO | Neurology | Leesburg, Virginia | K252873 |
| 2025-12-19 | Pari Respiratory Equipment, Inc. | eRapid with eTrack System CAF | Anesthesiology | Midlothian, Virginia | K251572 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
https://mentionfox.com/fda/510k/state/va