Cleared Traditional

K092538 - REFINE SUPPORT SYSTEM, MODEL 100.0100

K092538 is an FDA 510(k) clearance for REFINE SUPPORT SYSTEM, manufactured by Alure Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K092538 · Alure Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
198d
Days
Class 2
Risk

K092538 is an FDA 510(k) clearance for the REFINE SUPPORT SYSTEM, MODEL 100.0100. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Alure Medical, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 198 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092538

510(k) Number K092538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date March 05, 2010
Days to Decision 198 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 115d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 335
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K092538.
VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
K093932 · Ethicon GmbH · Apr 2010
PIVIT A/B ST AND PIVIT A/B ST-R
K093524 · Tyrx, Inc. · Mar 2010
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp. · Jan 2010
TIGR SURGICAL MESH , MODEL WK-6
K092224 · Novus Scientific Pte, Ltd. · Jan 2010
HYDROCOAT MESH
K090271 · Promethean Surgical Devices, Inc. · Jan 2010
K092538 · REFINE SUPPORT SYSTEM, MODEL 100.0100
Download PDF FDA Summary Alure Medical, Inc.