Cleared Abbreviated

K193662 - Ezlymph, Ezlymph M (FDA 510(k) Clearance)

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

K193662 · Eezcare Medical Corp · Cardiovascular device
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Feb 2021
Decision
408d
Days
Class 2
Risk

K193662 is an FDA 510(k) clearance for the Ezlymph, Ezlymph M. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Eezcare Medical Corp (New Taipei City 236, Taipei, TW). The FDA issued a Cleared decision on February 11, 2021 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Eezcare Medical Corp devices

Submission Details

510(k) Number K193662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2019
Decision Date February 11, 2021
Days to Decision 408 days
Submission Type Abbreviated
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
283d slower than avg
Panel avg: 125d · This submission: 408d
Pathway characteristics
Standards-based clearance path.

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

FDA 510k Consultants, LLC
John Gillespy

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 349
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