510(k) Report

FDA applicant

Best Medical International, Inc.

Springfield, VA6 decisions2004–20180 recalls

FDA records 6 decisions for Best Medical International, Inc. (Springfield, VA) from 2004 to 2018: 6 510(k) clearances. Most are in product codes JAQ (System, Applicator, Radionuclide…) and KXK (Source, Brachytherapy, Radionuclide). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Best Medical International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Best Medical International, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Best Medical International, 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?

  • JAQSystem, Applicator, Radionuclide, Remote-Controlled3decisions
  • KXKSource, Brachytherapy, Radionuclide3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K043117Best Radiopaque Strand; Best Radiopaque MarkerBest Medical International, Inc. · 20041cites it

What has FDA decided for it lately?

  • K162499Best Instruminal ApplicatorBest Medical International, Inc. · 2018
  • K132097Best Multi-Lumen Balloon Applicator for BrachytherapyBest Medical International, Inc. · 2013
  • K061638Best Strand and Best SpacerBest Medical International, Inc. · 2006
  • K043117Best Radiopaque Strand; Best Radiopaque MarkerBest Medical International, Inc. · 2004
  • K042786Best Model # 81-01 Series IR-192 SourcesBest Medical International, Inc. · 2004
  • K042586Best Breast Brachytherapy ApplicatorBest Medical International, Inc. · 2004

All 6 as Best Medical International, Inc. →