# FDA device clearances in Virginia: 40 since Nov 2024

Updated October 20, 2026.

FDA made 40 device decisions for applicants in Virginia from November 13, 2024 to October 20, 2026: 30 510(k) clearances and De Novo grants and 10 PMA approvals and supplements, for 21 applicants. The newest, K262093 on October 20, 2026, is Accuro XV from Rivanna Medical, Inc..

## The full list

FDA device clearances for applicants in Virginia: 40 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 1 row a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/state/virginia

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 40
- 510(k) and De Novo: 30
- PMA: 10
- Latest decision: October 20, 2026

## Newest decisions

The newest 40 of 40, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 20, 2026 | K262093 | Accuro XV | Rivanna Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | IYO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262093) |
| September 3, 2026 | P170012/S032 | HEMOBLAST™ Bellows | Dilon Technologies, Inc. | Virginia | Approved | PMA 180-day supplement | PMX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012S032) |
| August 10, 2026 | K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | ITX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254143) |
| July 24, 2026 | K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | ITX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261014) |
| July 24, 2026 | K253452 | Accuro 3S | Rivanna Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | IYO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253452) |
| June 27, 2026 | K261122 | MIST IC | Imagine Milling Technologies, LLC | Virginia | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261122) |
| June 18, 2026 | K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | QME | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254169) |
| May 13, 2026 | P190030/S004 | ActaStim-S | Theragen, Inc. | Virginia | Approved | PMA 180-day supplement | LOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190030S004) |
| April 28, 2026 | P170012/S031 | HEMOBLAST® Bellows | Dilon Technologies, Inc. | Virginia | Approved | PMA 180-day supplement | PMX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012S031) |
| April 20, 2026 | K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | Virginia | Substantially Equivalent | 510(k) traditional | LZH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253558) |
| April 9, 2026 | K254021 | Accuro XV | Rivanna Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | IYO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254021) |
| April 2, 2026 | P040029/S026 | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon... | Euclid Vision Corporation | Virginia | 30-day notice accepted | PMA 30-day notice | NUU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040029S026) |
| March 17, 2026 | K260546 | Q Pedicle Instruments | K2m, Inc. | Virginia | Substantially Equivalent | 510(k) special | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260546) |
| March 12, 2026 | P040029/S025 | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon... | Euclid Vision Corporation | Virginia | Approved | PMA 180-day supplement | NUU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040029S025) |
| March 6, 2026 | P040029/S021 | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A)... | Euclid Vision Corporation | Virginia | Approved | PMA 180-day supplement | NUU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040029S021) |
| February 17, 2026 | K260149 | Versus™ Catheter (VS110-9NB) | Liquet Medical, Inc. | Virginia | Substantially Equivalent | 510(k) special | QEY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260149) |
| February 10, 2026 | K253545 | Vulcan Spinal System | K2m, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253545) |
| February 6, 2026 | K252873 | Q Interbody Instruments | K2m, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252873) |
| December 19, 2025 | K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | CAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251572) |
| September 26, 2025 | K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | Virginia | Substantially Equivalent | 510(k) traditional | DXG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251275) |
| September 19, 2025 | K252647 | Tapestry Biointegrative Implant | Embody, Inc. | Virginia | Substantially Equivalent | 510(k) special | OWY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252647) |
| September 9, 2025 | K251682 | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | Virginia | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251682) |
| July 9, 2025 | K243731 | HEXIM Implant; Samwon General Abutments | P&a USA | Virginia | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243731) |
| June 24, 2025 | K243009 | MIST IC | Imagine Milling Technologies, LLC | Virginia | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243009) |
| June 20, 2025 | K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | Virginia | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243589) |
| June 18, 2025 | K243172 | Halyard Purple Nitrile\* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile\* Powder-Free Exam... | O&M Halyard, Inc. | Virginia | Substantially Equivalent | 510(k) abbreviated | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243172) |
| June 13, 2025 | K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | ITX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250469) |
| May 30, 2025 | K243010 | Fluidshield \* 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield \* 3 Surgical... | Owens & Minor (O&M) Halyard, Inc. | Virginia | Substantially Equivalent | 510(k) abbreviated | FXX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243010) |
| May 23, 2025 | P040029/S023 | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon... | Euclid Vision Corporation | Virginia | Approved | PMA 180-day supplement | NUU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040029S023) |
| May 23, 2025 | K243937 | Accuro 3S | Rivanna Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | IYO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243937) |
| April 25, 2025 | K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | Virginia | Substantially Equivalent | 510(k) traditional | QPB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244026) |
| April 2, 2025 | K242460 | Progenix Select Stim | Progenix, LLC | Virginia | Substantially Equivalent | 510(k) traditional | NUH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242460) |
| March 31, 2025 | P170012/S030 | HEMOBLAST™ Bellows | Dilon Technologies, Inc. | Virginia | 30-day notice accepted | PMA 30-day notice | PMX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012S030) |
| February 10, 2025 | K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | NFO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243063) |
| December 30, 2024 | K242804 | PAL Aspiration System | Microaire Surgical Instruments, LLC | Virginia | Substantially Equivalent | 510(k) traditional | QPB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242804) |
| December 23, 2024 | P040029/S024 | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A)... | Euclid Vision Corporation | Virginia | 30-day notice accepted | PMA 30-day notice | NUU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040029S024) |
| December 17, 2024 | K242558 | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy... | O&M Halyard, Inc. | Virginia | Substantially Equivalent | 510(k) abbreviated | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242558) |
| November 25, 2024 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | QEY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241851) |
| November 21, 2024 | K242799 | PliaFX Flo | Lifenet Health | Virginia | Substantially Equivalent | 510(k) traditional | MBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242799) |
| November 13, 2024 | P190030/S003 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | Virginia | Approved | PMA real-time process supplement | LOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190030S003) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Rivanna Medical, Inc. | 6 | October 20, 2026 |
| Euclid Vision Corporation | 5 | April 2, 2026 |
| Dilon Technologies, Inc. | 3 | September 3, 2026 |
| K2m, Inc. | 3 | March 17, 2026 |
| Microaire Surgical Instruments, LLC | 3 | June 20, 2025 |
| Imagine Milling Technologies, LLC | 2 | June 27, 2026 |
| Theragen, Inc. | 2 | May 13, 2026 |
| Liquet Medical, Inc. | 2 | February 17, 2026 |
| O&M Halyard, Inc. | 2 | June 18, 2025 |
| EM-TECH Solutions, Inc. | 1 | August 10, 2026 |
| Presage Security, Inc. d/b/a Presage Technologies, Inc. | 1 | June 18, 2026 |
| Luminoah | 1 | April 20, 2026 |
| Pari Respiratory Equipment, Inc. | 1 | December 19, 2025 |
| Caretaker Medical | 1 | September 26, 2025 |
| Embody, Inc. | 1 | September 19, 2025 |
| Springbok, Inc. (Dba Springbok Analytics) | 1 | September 9, 2025 |
| P&a USA | 1 | July 9, 2025 |
| Owens & Minor (O&M) Halyard, Inc. | 1 | May 30, 2025 |
| Progenix, LLC | 1 | April 2, 2025 |
| Raja Trading Company, Inc. | 1 | February 10, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 8 | October 20, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 7 | September 3, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 5 | April 2, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 4 | June 18, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 4 | May 13, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 4 | April 20, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 4 | March 17, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 3 | June 27, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 1 | December 19, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 24 | October 20, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 6 | September 3, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 3 | April 2, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 3 | March 17, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 3 | June 18, 2025 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 1 | November 13, 2024 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).