Cleared Traditional

K041077 - IMALUX OCT PROBE GUIDE

K041077 is an FDA 510(k) clearance for IMALUX OCT PROBE GUIDE, manufactured by Imalux Corporation. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K041077 · Imalux Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
60d
Days
Class 2
Risk

K041077 is an FDA 510(k) clearance for the IMALUX OCT PROBE GUIDE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Imalux Corporation (Cleveland, US). The FDA issued a Cleared decision on June 25, 2004 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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 - K041077

510(k) Number K041077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date June 25, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 420
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K041077.
PROMEDICAL SURGICAL DRAPES
K042131 · Promedical Products Co., Ltd. · Dec 2004
PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
K042137 · Promedical Products Co., Ltd. · Oct 2004
SABRESOURCE DRAPE
K041846 · Minrad, Inc. · Aug 2004
ALEXIS WOUND RETRACTOR
K031889 · Applied Medical Resources Corp. · Sep 2003
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
DEROYAL SURGICAL DRAPES BACKTABLE COVER
K030908 · Deroyal · Aug 2003
K041077 · IMALUX OCT PROBE GUIDE
Download PDF FDA Summary Imalux Corporation