Cleared Traditional

K070406 - ENDODRAPE

K070406 is an FDA 510(k) clearance for ENDODRAPE, manufactured by Vortek Surgical, LLC. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K070406 · Vortek Surgical, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
168d
Days
Class 2
Risk

K070406 is an FDA 510(k) clearance for the ENDODRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Vortek Surgical, LLC (Indianapolis, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K070406

510(k) Number K070406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2007
Decision Date July 30, 2007
Days to Decision 168 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 129d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KKX Drape, Surgical

All 420
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K070406.
ENDODRAPE(TM)
K080341 · Vortek Surgical, LLC · Jul 2008
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · Arrow Intl., Inc. · Oct 2007
GENERAL SURGERY DRAPES
K070432 · Welmed, Inc. · Sep 2007
JOYKEY SURGICAL DRAPES (STERILE)
K062480 · Joykey Industryial , Ltd. · Mar 2007
SURGICAL DRAPES
K061422 · Austin Medical, Inc. · Sep 2006
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
K061762 · Cardinal Health, Inc. · Aug 2006

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K070406 · ENDODRAPE
Download PDF FDA Summary Vortek Surgical, LLC