Cleared Traditional

K203310 - SyneCare 1000 Deep Vein Thrombosis Prev...

K203310 is an FDA 510(k) clearance for SyneCare 1000 Deep Vein Thrombosis Prev..., manufactured by Jiangsu Synecoun Medical Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K203310 · Jiangsu Synecoun Medical Technology Co., Ltd. · Cardiovascular device
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Apr 2021
Decision
143d
Days
Class 2
Risk

K203310 is an FDA 510(k) clearance for the SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Jiangsu Synecoun Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on April 2, 2021 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 Jiangsu Synecoun Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K203310

510(k) Number K203310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2020
Decision Date April 02, 2021
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 120
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K203310.
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