Cleared Traditional

K193476 - VariLymph 12 pro

K193476 is an FDA 510(k) clearance for VariLymph 12 pro, manufactured by Slk Medical GmbH. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K193476 · Slk Medical GmbH · Cardiovascular device
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Aug 2020
Decision
247d
Days
Class 2
Risk

K193476 is an FDA 510(k) clearance for the VariLymph 12 pro. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Slk Medical GmbH (Dortmund, DE). The FDA issued a Cleared decision on August 19, 2020 after a review of 247 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 Slk Medical GmbH devices

FDA 510(k) Submission Details - K193476

510(k) Number K193476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date August 19, 2020
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
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 122
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