Cleared Traditional

K152906 - Disposable High Pressure Injector Syringe

K152906 is an FDA 510(k) clearance for Disposable High Pressure Injector Syringe, manufactured by Wuxi Yushou Medical Appliances Co., Ltd.. The device is a Class 2 General Hospital device with product code DXT cleared through the Traditional 510(k) pathway after a 418-day FDA review.

K152906 · Wuxi Yushou Medical Appliances Co., Ltd. · General Hospital
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Nov 2016
Decision
418d
Days
Class 2
Risk

K152906 is an FDA 510(k) clearance for the Disposable High Pressure Injector Syringe. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Wuxi Yushou Medical Appliances Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on November 22, 2016 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Wuxi Yushou Medical Appliances Co., Ltd. devices

FDA 510(k) Submission Details - K152906

510(k) Number K152906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2015
Decision Date November 22, 2016
Days to Decision 418 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
289d slower than avg
Panel avg: 129d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 111
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K152906.
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