Cleared Traditional

K041923 - BIOBLANKET

K041923 is an FDA 510(k) clearance for BIOBLANKET, manufactured by Kensey Nash Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K041923 · Kensey Nash Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2004
Decision
54d
Days
Class 2
Risk

K041923 is an FDA 510(k) clearance for the BIOBLANKET. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 54 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.

View all Kensey Nash Corp. devices

FDA 510(k) Submission Details - K041923

510(k) Number K041923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2004
Decision Date September 08, 2004
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 76
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K041923.
BIOBLANKET SURGICAL MESH
K043259 · Kensey Nash Corp. · Aug 2005
SIS DERMAL AUGMENTATION STRAND
K050246 · Cook Biotech, Inc. · May 2005
SIS FISTULA PLUG
K050337 · Cook Biotech, Inc. · Mar 2005
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · Implex Corp. · Jul 2004
ACELL UBM SURGICAL MESH ML AND MLPLUS
K041140 · Acell, Inc. · Jul 2004
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
K040364 · Porex Surgical, Inc. · Jun 2004