Cleared Traditional

K212525 - Advcare Vial Direct to Bag (VDB) Needle...

K212525 is an FDA 510(k) clearance for Advcare Vial Direct to Bag (VDB) Needle..., manufactured by Advcare Medical. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K212525 · Advcare Medical · General Hospital
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Aug 2022
Decision
373d
Days
Class 2
Risk

K212525 is an FDA 510(k) clearance for the Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Advcare Medical (New Taipei City, TW). The FDA issued a Cleared decision on August 19, 2022 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Advcare Medical devices

FDA 510(k) Submission Details - K212525

510(k) Number K212525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2021
Decision Date August 19, 2022
Days to Decision 373 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 129d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 74
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K212525.
Vial Adapter
K222718 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Mar 2023
Vented Vial Transfer Pin
K221406 · Jiangsu Caina Medical Co.,Ltd · Oct 2022
Vented Vial Adapter 20mm
K213513 · West Pharma Services Il, Ltd. · Aug 2022
Vial Adapter Ø13mm
K220856 · Avenir Performance Europ?enne Medical (Apem) · Jun 2022
freeflex+ Transfer Adapter
K212445 · Fresenius Kabi AG · Jun 2022
IVX Fluid Transfer Set
K212530 · Omnicell, Inc. · Apr 2022