Cleared Special

Sterile High-pressure Angiographic Syringes for Single-use (K182289) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182289 · Shenzhen Baoan Medical Supplies Co., Ltd. · Cardiovascular device
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Oct 2018
Decision
48d
Days
Class 2
Risk

K182289 is an FDA 510(k) clearance for the Sterile High-pressure Angiographic Syringes for Single-use. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Shenzhen Baoan Medical Supplies Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 10, 2018 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen Baoan Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K182289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2018
Decision Date October 10, 2018
Days to Decision 48 days
Submission Type Special
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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

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 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 209
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