Cleared Traditional

K203178 - Flexitouch Plus System

K203178 is an FDA 510(k) clearance for Flexitouch Plus System, manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical). The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K203178 · Tactile Systems Technology, Inc. (Dba Tactile Medical) · Cardiovascular device
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Dec 2020
Decision
55d
Days
Class 2
Risk

K203178 is an FDA 510(k) clearance for the Flexitouch Plus System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Tactile Systems Technology, Inc. (Dba Tactile Medical) (New Brighton, US). The FDA issued a Cleared decision on December 20, 2020 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tactile Systems Technology, Inc. (Dba Tactile Medical) devices

FDA 510(k) Submission Details - K203178

510(k) Number K203178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2020
Decision Date December 20, 2020
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 Consultant

The Tamarack Group – Mpls, LLC
Lauren Barnes

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.

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All 115
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