Cleared Traditional

Disposable High Pressure Injector Syringe (K152906) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 51
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K152906.
ACISTCVi® Contrast Delivery System
K171646 · Acist Medical Systems, Inc. · Feb 2018
PRESS DUO elite, PRESS DUO elite AG
K173450 · Nemoto Kyorindo Co., Ltd. · Feb 2018
Merit Coronary Control Syringe
K163084 · Merit Medical Systems, Inc. · Jun 2017
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · Merit Medical Systems, Inc. · Jul 2016
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · Medline Industries, Inc. · Mar 2011
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009