Cleared Traditional

K012309 - RIWO SYSTEM TRAYS

K012309 is the FDA 510(k) clearance for RIWO SYSTEM TRAYS by Richard Wolf Medical Instruments Corp.. It is a Class 2 General Hospital device (product code FEB) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K012309 · Richard Wolf Medical Instruments Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
88d
Days
Class 2
Risk

K012309 is an FDA 510(k) clearance for the RIWO SYSTEM TRAYS. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on October 19, 2001 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K012309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date October 19, 2001
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K012309.
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
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871 · Biosearch Medical Products, Inc. · Mar 1997
MILL-ROSE RIGID SCOPE CLEANING BRUSHES
K954745 · Mill-Rose Laboratory · Nov 1995
EW-10 AND EW-20
K915402 · Olympus Corp. · Jun 1995