Cleared Traditional

K170279 - Disposable High Pressure Syringe

K170279 is an FDA 510(k) clearance for Disposable High Pressure Syringe, manufactured by Union Medical Shenzhen Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K170279 · Union Medical Shenzhen Co., Ltd. · Cardiovascular device
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Dec 2017
Decision
316d
Days
Class 2
Risk

K170279 is an FDA 510(k) clearance for the Disposable High Pressure Syringe. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Union Medical Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 12, 2017 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Union Medical Shenzhen Co., Ltd. devices

FDA 510(k) Submission Details - K170279

510(k) Number K170279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date December 12, 2017
Days to Decision 316 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
191d slower than avg
Panel avg: 125d · This submission: 316d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 177
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K170279.
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