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

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.

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