Cleared Special

K090489 - ABTHERA OPEN ABDOMEN DRESSING

K090489 is the FDA 510(k) clearance for ABTHERA OPEN ABDOMEN DRESSING by Kci USA, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 78-day FDA review.

K090489 · Kci USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
78d
Days
Class 2
Risk

K090489 is an FDA 510(k) clearance for the ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Kci USA, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 14, 2009 after a review of 78 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kci USA, Inc. devices

Submission Details

510(k) Number K090489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date May 14, 2009
Days to Decision 78 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 186
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K090489.
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659 · C.R. Bard, Inc. · Aug 2009
C-QUR V -PATCH MESH
K090909 · Atrium Medical Corp. · Jun 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934 · American Medical Systems, Inc. · Jun 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858 · Sofradim Production · May 2009
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc. · Mar 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009