Cleared Traditional

Flexitouch System (K153311) - FDA 510(k) Clearance

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

K153311 · Tactile Systems Technology, Inc. (Dba Tactile Medical) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
302d
Days
Class 2
Risk

K153311 is an FDA 510(k) clearance for the Flexitouch System. Classified as Sleeve, Head And Neck, Compressible (product code PPS), Class II - Special Controls.

Submitted by Tactile Systems Technology, Inc. (Dba Tactile Medical) (Minneapolis, US). The FDA issued a Cleared decision on September 14, 2016 after a review of 302 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 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. Elevated predicate reliance profile. 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 Tactile Systems Technology, Inc. (Dba Tactile Medical) devices

Submission Details

510(k) Number K153311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2015
Decision Date September 14, 2016
Days to Decision 302 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PPS Sleeve, Head And Neck, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
Definition Intended To Move Excess Fluid From The Target Area To Another Area Of The Body.
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.