510(k) Report

FDA applicant

Rivanna Medical, Inc.

Charlottesville, VA8 decisions2014–20260 recalls

FDA records 8 decisions for Rivanna Medical, Inc. (Charlottesville, VA) from 2014 to 2026: 8 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 139 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Rivanna Medical, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Rivanna Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2014: 12017: 12025: 22026 (partial year): 4
2014high 4 (2026) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Rivanna Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rivanna Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic6decisions
  • ITXTransducer, Ultrasonic, Diagnostic2decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 120 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 139 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K243937Accuro 3SRivanna Medical, Inc. · 20252cite it
  • K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 20142cite it
  • K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc. · 20251cites it
  • K171594AccuroRivanna Medical, LLC · 20171cites it

What has FDA decided for it lately?

  • K262093Accuro XVRivanna Medical, Inc. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc. · 2026
  • K254021Accuro XVRivanna Medical, Inc. · 2026
  • K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc. · 2025
  • K243937Accuro 3SRivanna Medical, Inc. · 2025
  • K171594AccuroRivanna Medical, LLC · 2017
  • K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014

All 6 as Rivanna Medical, Inc. →All 2 as Rivanna Medical, LLC →