Cleared Special

K101462 - ASCEND BLUE AC MESH

Also marketed or referenced as:
ASCEND BLUE PC MESH

K101462 is the FDA 510(k) clearance for ASCEND BLUE AC MESH by Caldera Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 82-day FDA review.

K101462 · Caldera Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
82d
Days
Class 2
Risk

K101462 is an FDA 510(k) clearance for the ASCEND BLUE AC MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on August 16, 2010 after a review of 82 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 Caldera Medical, Inc. devices

Submission Details

510(k) Number K101462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2010
Decision Date August 16, 2010
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 K101462.
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
K102766 · C.R. Bard, Inc. · Dec 2010
PARIETEX PLUG AND PATCH
K101519 · Sofradim Production · Nov 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · Smith & Nephew, Inc. · Sep 2010
PARIE TENE PROGRIP MESH
K101197 · Sofradim Production · May 2010
TORNIER SURGICAL MESH
K093799 · Tornier, Inc. · Apr 2010
VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010