510(k) Report

FDA applicant

Medifun Corporation

Taichung City, TW2 decisions2023–20240 recalls

FDA records 2 decisions for Medifun Corporation (Taichung City, TW) from 2023 to 2024: 2 510(k) clearances. Most are in product codes QRL (Multiple Use Blood Lancet For Single Patient…) and FMK (Single Use Only Blood Lancet With An Integral…). Its devices cite 2 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 and plastic surgery panel, where it files most

How often FDA has decided Medifun Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Medifun Corporation by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QRLMultiple Use Blood Lancet For Single Patient Use Only1decision
  • FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K241750Medifun Safety Lancet ( MSL1 series)Medifun Corporation · 2024
  • K231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation · 2023

All 2 as Medifun Corporation →