Cleared Traditional

K052691 - SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES

K052691 is an FDA 510(k) clearance for SURETEK MEDICAL REPROCESSED COMPRESSION..., manufactured by Suretek Medical. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K052691 · Suretek Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
231d
Days
Class 2
Risk

K052691 is an FDA 510(k) clearance for the SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Suretek Medical (Greenville, US). The FDA issued a Cleared decision on May 17, 2006 after a review of 231 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.

FDA 510(k) Submission Details - K052691

510(k) Number K052691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date May 17, 2006
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
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 345
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K052691.
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K051227 · Renu Medical, Inc. · Apr 2006
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
K051438 · Alliance Medical, Inc. · Apr 2006
K052691 · SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
Download PDF FDA Summary Suretek Medical