Cleared Traditional

K160190 - Sunmed Control Syringes

K160190 is an FDA 510(k) clearance for Sunmed Control Syringes, manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K160190 · Sunny Medical Device (Shenzhen) Co., Ltd. · Cardiovascular device
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Nov 2016
Decision
288d
Days
Class 2
Risk

K160190 is an FDA 510(k) clearance for the Sunmed Control Syringes. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on November 10, 2016 after a review of 288 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunny Medical Device (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K160190

510(k) Number K160190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date November 10, 2016
Days to Decision 288 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 125d · This submission: 288d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 163
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K160190.
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
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Ecomed Disposable Angiographic Syringes
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Disposable High Pressure Injector Syringe
K152906 · Wuxi Yushou Medical Appliances Co., Ltd. · Nov 2016
MR Syringe Dual Pack for Solaris Injectors
K161471 · Coeur, Inc. · Oct 2016
DyeVert NG Contrast Modulation System
K161505 · Osprey Medical, Inc. · Aug 2016
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · Merit Medical Systems, Inc. · Jul 2016