# K050538: Imc Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Medsurg Connection, Inc.
- Decided: Jun 7, 2005 after 97 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- 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
Longest line of descent: 1 generation back to K030365 (2003). 1 ancestor in all.
3 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)
- K030365: Deroyal Drapes, Sterile, Non-Sterile, Deroyal Industries, Inc. (2003) Summary page 1.

## Most influential descendants
- 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

## Indications for use
This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures. This submission includes drapes that will be sold both sterile and non-sterile.ISO Non-sterile drapes are to be sold to OEMs for EtO sterilization according to 11135. Sterile drapes are to be sold directly to users after EtO sterilization, validated to ISO 11135.

Source page: https://510kreport.com/device/K050538
Methodology: https://510kreport.com/methodology