510(k) Report

FDA applicant

Milestone Scientific, Inc.

Washington, DC4 decisions2006–20231 recall

FDA records 4 decisions for Milestone Scientific, Inc. (Washington, DC) from 2006 to 2023: 4 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and EJI (Syringe, Cartridge). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2023

2017: 12023: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FMFSyringe, Piston2decisions
  • EJISyringe, Cartridge1decision
  • FRNPump, Infusion1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K161883CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 20171cites it
  • K053554CompufloMilestone Scientific, Inc. · 20061cites it

What has FDA decided for it lately?

  • K221702CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2023
  • K161883CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. · 2017
  • K061904Compudent StaMilestone Scientific, Inc. · 20061 recall
  • K053554CompufloMilestone Scientific, Inc. · 2006

All 4 as Milestone Scientific, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061904Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue.…Feb 11, 2015Class III