Cleared Traditional

K232577 - Radial Compression Device (FDA 510(k) Clearance)

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

K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Cardiovascular device
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Jan 2024
Decision
146d
Days
Class 2
Risk

K232577 is an FDA 510(k) clearance for the Radial Compression Device. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Ningbo Dizegens Medical Science Co.,Ltd (Ningo, US). The FDA issued a Cleared decision on January 18, 2024 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ningbo Dizegens Medical Science Co.,Ltd devices

Submission Details

510(k) Number K232577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2023
Decision Date January 18, 2024
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 201
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K232577.
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PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · Compression Works, Inc. · Mar 2023
VIOLA
K230248 · Vascular Graft Solutions, Ltd. · Feb 2023