# K934688: Sterile Design

- Pathway: 510(k) (Traditional)
- Applicant: Sterile Design, Inc.
- Decided: Mar 16, 1994 after 167 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041080: Surgical Drape Kit - D.I.R.R.a. SRL (2004), 1 descendant of its own
- K110724: Surgical Procedure Packs (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K934688
Methodology: https://510kreport.com/methodology