Cleared Traditional

K060004 - CALDERA MESH

K060004 is an FDA 510(k) clearance for CALDERA MESH, manufactured by Caldera 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 50-day FDA review.

K060004 · Caldera Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
50d
Days
Class 2
Risk

K060004 is an FDA 510(k) clearance for the CALDERA 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 February 22, 2006 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060004

510(k) Number K060004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2006
Decision Date February 22, 2006
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 336
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K060004.
ATRIUM MEDICAL CORPORATION C-QUR MESH
K050311 · Atrium Medical Corp. · Mar 2006
VITAMESH MACROPOROUS PP SURGICAL MESH
K060520 · Proxy Biomedical , Ltd. · Mar 2006
POPMESH
K053424 · Caldera Medical, Inc. · Feb 2006
SPORTMESH
K052830 · Artimplant AB · Jan 2006
OPTILENE MESH LP
K053158 · Aesculap, Inc. · Jan 2006
TYRX SURGICAL MESH, MODEL SMPC-0501
K052864 · Tyrx Pharma, Inc. · Dec 2005
K060004 · CALDERA MESH
Download PDF FDA Summary Caldera Medical, Inc.