Cleared Traditional

Compression Therapy Device (K191856) - FDA 510(k) Clearance

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

K191856 · Guangzhou Longest Science & Technology Co., Ltd. · Cardiovascular device
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Mar 2020
Decision
252d
Days
Class 2
Risk

K191856 is an FDA 510(k) clearance for the Compression Therapy Device. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Guangzhou Longest Science & Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 19, 2020 after a review of 252 days - an extended review cycle.

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 Guangzhou Longest Science & Technology Co., Ltd. devices

Submission Details

510(k) Number K191856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2019
Decision Date March 19, 2020
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 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 - JOW Sleeve, Limb, Compressible

All 91
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K191856.
Zeroveno
K192337 · Dimedi Co., Ltd. · Jun 2020
Koya Ripple
K193288 · Koya, Inc. · Jun 2020
Aria System
K200564 · Inova Labs · Apr 2020
Ezvena IPC, Ezvena SQS
K191937 · Eezcare Medical Corp · Jan 2020
VenaPro Vascular Therapy System
K193020 · Innovamed Health, LLC · Dec 2019
AIROS 8 Sequential Compression Device
K193068 · Airos Medical, Inc. · Dec 2019