Cleared Traditional

K251788 - Extension tube

K251788 is an FDA 510(k) clearance for Extension tube, manufactured by Zhuhai DR Medical Instruments Co., Ltd.. The device is a Class 2 General Hospital device with product code DXT cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K251788 · Zhuhai DR Medical Instruments Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
267d
Days
Class 2
Risk

K251788 is an FDA 510(k) clearance for the Extension tube. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Zhuhai DR Medical Instruments Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on March 5, 2026 after a review of 267 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.

FDA 510(k) Submission Details - K251788

510(k) Number K251788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2025
Decision Date March 05, 2026
Days to Decision 267 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
138d slower than avg
Panel avg: 129d · This submission: 267d
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 210
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K251788.
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High Pressure Tubing
K244038 · Shandong Int Medical Instruments Co., Ltd. · Sep 2025
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
K251788 · Extension tube
Download PDF FDA Summary Zhuhai DR Medical Ins…