# K003229: Biopatch Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Oct 26, 2001 after 381 days
- Product code: SEL (Securement Wound Dressing For Reduction Of Infection)
- Device class: U
- 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 K895920 (1991). 1 ancestor in all.
31 later devices descend from it; 8 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895920: Vitapatch Pin Protection Device for Percutaneous, Vitaphore Corp. (1991) Summary page 5.

## Most influential descendants
- K063458: 3M Tegaderm CHG Dressing (2007), 16 descendants of its own
- K080779: Irrisept Wound Cleansing System (2009), 9 descendants of its own
- K202222: Irrisept Wound Debridement and Cleansing System (2020), 7 descendants of its own
- K080620: Modification to 3M Tegaderm CHG Dressing (2008), 7 descendants of its own
- K210536: Irrisept Antimicrobial Wound Lavage (2021), 6 descendants of its own

## Indications for use
BIOPATCH* Antimicrobial Dressing containing Chlorhexidine gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheter, drains, chest tubes, externally placed orthopedic pins, and epidural catheters. It is also intended to reduce local infections, catheter related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.

Source page: https://510kreport.com/device/K003229
Methodology: https://510kreport.com/methodology