# K030365: Deroyal Drapes, Sterile, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Apr 29, 2003 after 84 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050538: Imc Drapes (2005), 3 descendants of its own
- K052169: Imc Surgical Drapes (2005), 2 descendants of its own
- K100208: Imc Surgical Drape (2010), 0 descendants of its own
- K070432: General Surgery Drapes (2007), 0 descendants of its own

## Recalls of this device
- Sep 9, 2004 · Not classified · Z-1494-04: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Sep 9, 2004 · Not classified · Z-1490-04: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Sep 9, 2004 · Not classified · Z-1493-04: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Sep 9, 2004 · Not classified · Z-1495-04: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Sep 9, 2004 · Not classified · Z-1492-04: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Sep 9, 2004 · Not classified · Z-1491-04: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.

Source page: https://510kreport.com/device/K030365
Methodology: https://510kreport.com/methodology