Cleared Traditional

Sterile High-pressure Angiographic Syringes for Single-use (K211564) - FDA 510(k) Clearance

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

K211564 · Shenzhen Boon Medical Supply Co., Ltd. · General Hospital
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Oct 2021
Decision
152d
Days
Class 2
Risk

K211564 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 Boon Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 19, 2021 after a review of 152 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Boon Medical Supply Co., Ltd. devices

Submission Details

510(k) Number K211564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2021
Decision Date October 19, 2021
Days to Decision 152 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 129d · This submission: 152d
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 48
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K211564.
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · Shenzhen Boon Medical Supply Co., Ltd. · Aug 2024
Disposable High-pressure Extension Lines
K230668 · Precision Medical Plastics , Ltd. · Jun 2024
High Pressure Tubing
K232388 · Ningbo Dizegens Medical Science Co.,Ltd · Nov 2023
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
K203004 · Acist Medical Systems, Inc. · Dec 2020
Sterile High-pressure Angiographic Syringes for single-use
K201395 · Youwo (Guangzhou) Medical Device Co., Ltd. · Oct 2020
Sterile High-pressure Angiographic Syringes for Single-use
K192657 · Shenzhen Boon Medical Supply Co., Ltd. · Aug 2020