Cleared Traditional

K090012 - DISPOSABLE INFUSION SET

K090012 is an FDA 510(k) clearance for DISPOSABLE INFUSION SET, manufactured by Shan Dong Wei Gao Group Medical Polymer Products. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K090012 · Shan Dong Wei Gao Group Medical Polymer Products · General Hospital
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Jun 2009
Decision
160d
Days
Class 2
Risk

K090012 is an FDA 510(k) clearance for the DISPOSABLE INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Shan Dong Wei Gao Group Medical Polymer Products (Shan Nan Er Rd., Shanghai, CN). The FDA issued a Cleared decision on June 11, 2009 after a review of 160 days - an extended review cycle.

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. Standard predicate reliance. 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 Shan Dong Wei Gao Group Medical Polymer Products devices

FDA 510(k) Submission Details - K090012

510(k) Number K090012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date June 11, 2009
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 657
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K090012.
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
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NEXUS INJECTION SITE, MODEL NIS-8
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A6 LUER ACCESS DEVICE
K083723 · B.Braun Medical, Inc. · Jun 2009
INTRAVENOUS POWER INJECTOR EXTENSION SET
K090134 · C.R. Bard, Inc. · Apr 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · Icu Medical, Inc. · Apr 2009