Cleared Traditional

K061899 - EVOTECH INTEGRATED ENDOSCOPE DISINFECTI...

K061899 is the FDA 510(k) clearance for EVOTECH INTEGRATED ENDOSCOPE DISINFECTI... by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code FEB) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K061899 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
115d
Days
Class 2
Risk

K061899 is an FDA 510(k) clearance for the EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on October 26, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - 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.

View all Advanced Sterilization Products devices

Submission Details

510(k) Number K061899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date October 26, 2006
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FEB Accessories, Cleaning, For Endoscope

All 24
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K061899.
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
K103264 · Olympus Medical Systems Corporation · Feb 2011
ENDOSCOPE REPROCESSOR OER-PRO
K093106 · Olympus Medical Systems Corporation · Feb 2010
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
K082392 · Advanced Sterilization Products · Nov 2008
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K040883 · Advanced Sterilization Products · Mar 2005
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp. · Oct 2001
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871 · Biosearch Medical Products, Inc. · Mar 1997