Cleared Traditional

K092387 - MEDIVATORS DSD EDGE ENDOSCOPE REPROCESS...

K092387 is the FDA 510(k) clearance for MEDIVATORS DSD EDGE ENDOSCOPE REPROCESS... by Minntech Corp.. It is a Class 2 General Hospital device (product code FEB) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K092387 · Minntech Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
243d
Days
Class 2
Risk

K092387 is an FDA 510(k) clearance for the MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on April 5, 2010 after a review of 243 days - an extended review cycle.

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 Minntech Corp. devices

Submission Details

510(k) Number K092387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date April 05, 2010
Days to Decision 243 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 129d · This submission: 243d
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 19
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K092387.
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · STERIS Corporation · Dec 2018
ENDOSCOPE REPROCESSOR OER-MINI
K120357 · Olympus Medical Systems Corp. · Dec 2012
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
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