Cleared Traditional

K203847 - Reprocessed Tri Pulse Compression Garment

K203847 is an FDA 510(k) clearance for Reprocessed Tri Pulse Compression Garment, manufactured by Renu Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K203847 · Renu Medical, Inc. · Cardiovascular device
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May 2021
Decision
127d
Days
Class 2
Risk

K203847 is an FDA 510(k) clearance for the Reprocessed Tri Pulse Compression Garment. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on May 7, 2021 after a review of 127 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 Renu Medical, Inc. devices

FDA 510(k) Submission Details - K203847

510(k) Number K203847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2020
Decision Date May 07, 2021
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 122
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K203847.
WoundExpress
K211200 · Huntleigh Healthcare , Ltd. · Sep 2021
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Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K210417 · Bio Compression Systems, Inc. · May 2021
Dayspring
K210885 · Koya Medical, Inc. · Apr 2021
DVT-PRO
K203353 · Daesung Maref Co., Ltd. · Apr 2021
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
K203310 · Jiangsu Synecoun Medical Technology Co., Ltd. · Apr 2021