Cleared Traditional

K061430 - SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR

K061430 is an FDA 510(k) clearance for SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR, manufactured by Custom Ultrasonics. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K061430

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
Combination Product No
PCCP Authorized No
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.

FEB Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K061430.
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
K082988 · Medivators Reprocessing Systems · Feb 2009
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
K082392 · Advanced Sterilization Products · Nov 2008
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
K063876 · Medivators Reprocessing Systems · Jun 2007
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K061899 · Advanced Sterilization Products · Oct 2006
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
K060458 · Langford IC Systems, Inc. · Oct 2006
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K040883 · Advanced Sterilization Products · Mar 2005