Cleared Special

External Counterpulsation System, Soulaire (K202108) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202108 · Vamed Medical Instrument Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
29d
Days
Class 2
Risk

K202108 is an FDA 510(k) clearance for the External Counterpulsation System, Soulaire. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Vamed Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on August 28, 2020 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vamed Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K202108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2020
Decision Date August 28, 2020
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRN Device, Counter-pulsating, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5225
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 Consultant

Guangzhou Keda Biological Tech Co., Ltd.
Jet Li

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRN Device, Counter-pulsating, External

All 33
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K202108.
Pression Wave PRO External Counter-Pulsation System
K250756 · Pression, Inc. · Dec 2025
Enhanced External Counter Pulsation Device Plus Omay-A
K191955 · Omay(Guangzhou)Med Technologies Co., Ltd. · Aug 2020
External Counterpulsation System
K190683 · Vamed Medical Instrument Co., Ltd. · Sep 2019
Pure Flow External Counter-Pulsation Device
K173483 · Xtreem Pulse, LLC · May 2018