Cleared Traditional

K253555 - Flexitouch® Plus Advanced Pneumatic Compression System

K253555 is an FDA 510(k) clearance for Flexitouch Plus Advanced Pneumatic Comp..., manufactured by Tactile Medical. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K253555 · Tactile Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
259d
Days
Class 2
Risk

K253555 is an FDA 510(k) clearance for the Flexitouch® Plus Advanced Pneumatic Compression System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Tactile Medical (Minneapolis, US). The FDA issued a Cleared decision on July 31, 2026 after a review of 259 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 Tactile Medical devices

FDA 510(k) Submission Details - K253555

510(k) Number K253555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2025
Decision Date July 31, 2026
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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

DuVal & Associates, P.A.
Mark Spreeman

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 316
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K253555.
Sequential Circulator (SC-4004-DL, SC-4008-DL)
K261807 · Bio Compression Systems, Inc. · Sep 2026
DVT Garment
K253386 · Vistar Medical Supplies Co., Ltd. · Jun 2026
Compression Therapy Device (LGT-2202DVT)
K250242 · Guangzhou Longest Medical Technology Co., Ltd. · Apr 2026
NanoPress 760A-BT (760A-BT)
K254267 · Mego Afek , Ltd. · Feb 2026
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · Bio Compression Systems, Inc. · Dec 2025
Sequential Compression System (SCD600)
K250190 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025