Cleared Traditional

External Counterpulsation System (K190683) - FDA 510(k) Clearance

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

K190683 · Vamed Medical Instrument Co., Ltd. · Cardiovascular device
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Sep 2019
Decision
176d
Days
Class 2
Risk

K190683 is an FDA 510(k) clearance for the External Counterpulsation System. 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 September 10, 2019 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - 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 Vamed Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K190683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2019
Decision Date September 10, 2019
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Testing 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 K190683.
Pression Wave PRO External Counter-Pulsation System
K250756 · Pression, Inc. · Dec 2025
External Counterpulsation System, Soulaire
K202108 · Vamed Medical Instrument Co., Ltd. · Aug 2020
Enhanced External Counter Pulsation Device Plus Omay-A
K191955 · Omay(Guangzhou)Med Technologies Co., Ltd. · Aug 2020
Pure Flow External Counter-Pulsation Device
K173483 · Xtreem Pulse, LLC · May 2018