Cleared Traditional

K040162 - CORRESTORE PATCH SYSTEM

K040162 is an FDA 510(k) clearance for CORRESTORE PATCH SYSTEM, manufactured by Somanetics Corp.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K040162 · Somanetics Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
50d
Days
Class 2
Risk

K040162 is an FDA 510(k) clearance for the CORRESTORE PATCH SYSTEM. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Somanetics Corp. (Troy, US). The FDA issued a Cleared decision on March 16, 2004 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight 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 - K040162

510(k) Number K040162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date March 16, 2004
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 83
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K040162.
PFA PATCH
K041736 · Peritec Biosciences, LLC · Jan 2005
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
K040415 · Synovis Surgical Innovations · Apr 2004
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
K031948 · Pm Devices, Inc. · Sep 2003
CORRESTORE PATCH SYSTEM
K031586 · Somanetics Corp. · Aug 2003
CHASE CARDIOVASCULAR PATCH KIT
K022093 · Chase Medical, Inc. · Sep 2002
K040162 · CORRESTORE PATCH SYSTEM
Download PDF FDA Summary Somanetics Corp.