Cleared Traditional

K191107 - Plexus

K191107 is an FDA 510(k) clearance for Plexus, manufactured by Alleva Medical (D.G), Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K191107 · Alleva Medical (D.G), Ltd. · Cardiovascular device
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Aug 2019
Decision
123d
Days
Class 2
Risk

K191107 is an FDA 510(k) clearance for the Plexus. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Alleva Medical (D.G), Ltd. (Shek Mun, HK). The FDA issued a Cleared decision on August 27, 2019 after a review of 123 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 Alleva Medical (D.G), Ltd. devices

FDA 510(k) Submission Details - K191107

510(k) Number K191107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2019
Decision Date August 27, 2019
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
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 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K191107.
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