Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices— 510(k) K212525

Name: FDA 510(k) clearance K212525
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Substantially Equivalent

Advcare Medical

FDA 510(k) clearance K212525 for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices, Substantially Equivalent on 2022-08-19. Applicant: Advcare Medical. Device class: 2.

Clearance details

Applicant: Advcare Medical
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2021-08-11
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHI

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K252987 — ADRx Admixture Device2026-06-12
K260301 — Vial Adapter2026-06-05
K250345 — Medline Bag Decanter2025-10-24
K251715 — FlowArt® Vial Access Device Vented2025-10-14
K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more2025-09-16

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.