# K040683: Bioderm Sciences Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Bioderm Sciences, Inc.
- Decided: Jun 4, 2004 after 80 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 2 generations back to K935060 (1994). 5 ancestors in all.
29 later devices descend from it; 4 cite it directly.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993969: Saljet Single Dose Sterile Saline Topical Solution, Winchester Laboratories, LLC (1999) Summary page 1.
- K972185: 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride, Steripak, Ltd. (1998) Summary page 1.
- K941999: Hypertonic Saline Wet Dressing - Sterile, Trinity Laboratories, Inc. (1994) Summary page 1.
- K945802: Dermagran Wound Cleanser with Zinc, Derma Sciences, Inc. (1995) Summary page 1.

## Most influential descendants
- K063063: Silvacide Skin & Wound Moisturizing Solution (2007), 14 descendants of its own
- K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 (2008), 13 descendants of its own
- K042084: Bioderm Sciences Wound Healing Spray (2005), 13 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K083042: Wound Flush, Sterile Water & Normal Saline (2008), 7 descendants of its own

## Indications for use
BioDerm Sciences Wound Solution is intended to cleanse, irrigate and externally manage dernal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and full-thickness wounds, bums and ulcers (diabetic, venous stasis, pressure). It is meant to be used in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).

Source page: https://510kreport.com/device/K040683
Methodology: https://510kreport.com/methodology