# K965201: O.R. Scrub Prep Tray, Sterile, Disposable

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Laboratories, Inc.
- Decided: Feb 14, 1997 after 50 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K965201
Methodology: https://510kreport.com/methodology