Cleared Traditional

K191827 - Sunmed Disposable Angio-Closure Pads

K191827 is the FDA 510(k) clearance for Sunmed Disposable Angio-Closure Pads by Sunny Medical Device (Shenzhen) Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K191827 · Sunny Medical Device (Shenzhen) Co., Ltd. · Cardiovascular device
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Mar 2020
Decision
252d
Days
Class 2
Risk

K191827 is an FDA 510(k) clearance for the Sunmed Disposable Angio-Closure Pads. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on March 16, 2020 after a review of 252 days - an extended review cycle.

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 Sunny Medical Device (Shenzhen) Co., Ltd. devices

Submission Details

510(k) Number K191827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2019
Decision Date March 16, 2020
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
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 61
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K191827.
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K180723 · Merit Medical Systems, Inc. · Apr 2018