Cleared Traditional

Disposable High-pressure Extension Lines (K230668) - FDA 510(k) Clearance

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

K230668 · Precision Medical Plastics , Ltd. · General Hospital
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Jun 2024
Decision
462d
Days
Class 2
Risk

K230668 is an FDA 510(k) clearance for the Disposable High-pressure Extension Lines. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Precision Medical Plastics , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 14, 2024 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Precision Medical Plastics , Ltd. devices

Submission Details

510(k) Number K230668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2023
Decision Date June 14, 2024
Days to Decision 462 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 129d · This submission: 462d
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 82
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K230668.
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
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
High Pressure Tubing
K232388 · Ningbo Dizegens Medical Science Co.,Ltd · Nov 2023
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