# K052169: Imc Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection, Inc.
- Decided: Nov 17, 2005 after 100 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: 2 generations back to K030365 (2003). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K050538: Imc Drapes, Intl. Medsurg Connection, Inc. (2005) Summary page 1.

## Most influential descendants
- 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. Non-sterile drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.

Source page: https://510kreport.com/device/K052169
Methodology: https://510kreport.com/methodology