Cleared Traditional

K061430 - SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR

K061430 is the FDA 510(k) clearance for SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR by Custom Ultrasonics. It is a Class 2 General Hospital device (product code FEB) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K061430 · Custom Ultrasonics · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
234d
Days
Class 2
Risk

K061430 is an FDA 510(k) clearance for the SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Custom Ultrasonics (Ivyland, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 234 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 Custom Ultrasonics devices

Submission Details

510(k) Number K061430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2006
Decision Date January 12, 2007
Days to Decision 234 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
105d slower than avg
Panel avg: 129d · This submission: 234d
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 26
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K061430.
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
K092387 · Minntech Corp. · Apr 2010
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
K061899 · Advanced Sterilization Products · Oct 2006
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K040883 · Advanced Sterilization Products · Mar 2005
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp. · Oct 2001