Cleared Traditional

K232388 - High Pressure Tubing

K232388 is an FDA 510(k) clearance for High Pressure Tubing, manufactured by Ningbo Dizegens Medical Science Co.,Ltd. The device is a Class 2 General Hospital device with product code DXT cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K232388 · Ningbo Dizegens Medical Science Co.,Ltd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
104d
Days
Class 2
Risk

K232388 is an FDA 510(k) clearance for the High Pressure Tubing. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Ningbo Dizegens Medical Science Co.,Ltd (Ningbo, CN). The FDA issued a Cleared decision on November 21, 2023 after a review of 104 days - within the typical 510(k) review window.

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 Ningbo Dizegens Medical Science Co.,Ltd devices

FDA 510(k) Submission Details - K232388

510(k) Number K232388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2023
Decision Date November 21, 2023
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
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 General Hospital devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 110
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K232388.
Disposable Syringe (Kit)
K242212 · Nemoto Kyorindo Co., Ltd. · Aug 2024
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
Sterile High-pressure Angiographic Syringes for Single-use
K211564 · Shenzhen Boon Medical Supply Co., Ltd. · Oct 2021
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