Cleared Traditional

Enhanced External Counter Pulsation Device Plus Omay-A (K191955) - FDA 510(k) Clearance

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

K191955 · Omay(Guangzhou)Med Technologies Co., Ltd. · Cardiovascular device
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Aug 2020
Decision
380d
Days
Class 2
Risk

K191955 is an FDA 510(k) clearance for the Enhanced External Counter Pulsation Device Plus Omay-A. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Omay(Guangzhou)Med Technologies Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 5, 2020 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Omay(Guangzhou)Med Technologies Co., Ltd. devices

Submission Details

510(k) Number K191955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2019
Decision Date August 05, 2020
Days to Decision 380 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
255d slower than avg
Panel avg: 125d · This submission: 380d
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

Chonconn Medical Device Consulting Co., Ltd.
Kevin Wang

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 K191955.
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