Cleared Traditional

K153685 - Sunmed Haemostatic Valves

K153685 is the FDA 510(k) clearance for Sunmed Haemostatic Valves by Sunny Medical Device (Shenzhen) Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K153685 · Sunny Medical Device (Shenzhen) Co., Ltd. · Cardiovascular device
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Oct 2016
Decision
296d
Days
Class 2
Risk

K153685 is an FDA 510(k) clearance for the Sunmed Haemostatic Valves. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on October 13, 2016 after a review of 296 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 K153685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2015
Decision Date October 13, 2016
Days to Decision 296 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 125d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 499
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