# K012309: Riwo System Trays

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Oct 19, 2001 after 88 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Instrument Container 8582.06, 8584.06: named in the summary without a submission number
- (no number) Micropac, Endopak, Scopepak, Multipak: named in the summary without a submission number
- (no number) Scope trays, Silicone Nipple Mat System, Standard Sterilization Containers: named in the summary without a submission number
- (no number) C.A.S.E. System: Containers and Baskets: named in the summary without a submission number
- (no number) Instrument Protection and Sterilizing System: named in the summary without a submission number

## Indications for use
The RIWO System Trays 38201.xxx, 38202.xxx, 38301.xxx have been designed to hold devices during sterile storage, transport, and while undergoing steam and ethylene oxide sterilization.

Source page: https://510kreport.com/device/K012309
Methodology: https://510kreport.com/methodology