Cleared Traditional

K211200 - WoundExpress (FDA 510(k) Clearance)

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

K211200 · Huntleigh Healthcare , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
134d
Days
Class 2
Risk

K211200 is an FDA 510(k) clearance for the WoundExpress. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Huntleigh Healthcare , Ltd. (Cardiff, GB). The FDA issued a Cleared decision on September 3, 2021 after a review of 134 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 Huntleigh Healthcare , Ltd. devices

Submission Details

510(k) Number K211200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2021
Decision Date September 03, 2021
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K211200.
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
VenAir, Sequential Compression System (9P-089000)
K251466 · Wellell, Inc. · Oct 2025
PlasmaFlow X Compression Sleeve Device (XPF0001)
K251446 · Manamed, LLC · Sep 2025