Cleared Traditional

K040835 - PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16

K040835 is an FDA 510(k) clearance for PERIPATCH SHEET, manufactured by Pm Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K040835 · Pm Devices, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
76d
Days
Class 2
Risk

K040835 is an FDA 510(k) clearance for the PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Pm Devices, Inc. (Richmond, Bc, CA). The FDA issued a Cleared decision on June 15, 2004 after a review of 76 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 Pm Devices, Inc. devices

FDA 510(k) Submission Details - K040835

510(k) Number K040835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2004
Decision Date June 15, 2004
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
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 94
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K040835.
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
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K040868 · Genzyme Corp. · Jun 2004
ACELL UBM SURGICAL MESH
K040621 · Acell, Inc. · Apr 2004
SIS PLASTIC SURGERY MATRIX
K034039 · Cook Biotech, Inc. · Feb 2004