Cleared Traditional

K170216 - Flexitouch System

K170216 is an FDA 510(k) clearance for Flexitouch 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 122-day FDA review.

K170216 · Tactile Systems Technology, Inc. (Dba Tactile Medical) · Cardiovascular device
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May 2017
Decision
122d
Days
Class 2
Risk

K170216 is an FDA 510(k) clearance for the Flexitouch System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Tactile Systems Technology, Inc. (Dba Tactile Medical) (Minneapolis, US). The FDA issued a Cleared decision on May 26, 2017 after a review of 122 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 Tactile Systems Technology, Inc. (Dba Tactile Medical) devices

FDA 510(k) Submission Details - K170216

510(k) Number K170216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2017
Decision Date May 26, 2017
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 316
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