510(k) Report

FDA applicant

Azur Medical Company, Inc.

Richmond, VA4 decisions2021–20240 recalls

FDA records 4 decisions for Azur Medical Company, Inc. (Richmond, VA) from 2021 to 2024: 4 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 227 days from receipt to decision, against 193 for FDA’s reviews in the same codes and years. Its devices cite 4 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2024

2021: 22022: 12024: 1
2021high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Azur Medical Company, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Azur Medical Company, 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?

  • FMFSyringe, Piston2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision
  • FXXMask, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 227 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 193 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K211214Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc. · 20213cite it
  • K211211Sterile syringes for single use with/without needleAzur Medical Company, Inc. · 20211cites it

What has FDA decided for it lately?

  • K231719Medical Surgical MaskAzur Medical Company, Inc. · 2024
  • K211210Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc. · 2022
  • K211214Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc. · 2021
  • K211211Sterile syringes for single use with/without needleAzur Medical Company, Inc. · 2021

All 4 as Azur Medical Company, Inc. →