# K914174: Sterile Disposable Wet Skin Scrub Tray

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Inspection Co., Inc.
- Decided: Feb 24, 1992 after 159 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 21, 2006 · Not classified · Z-0268-2007: The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.

Source page: https://510kreport.com/device/K914174
Methodology: https://510kreport.com/methodology