# K042084: Bioderm Sciences Wound Healing Spray

- Pathway: 510(k) (Traditional)
- Applicant: Bioderm Sciences, Inc.
- Decided: Jun 15, 2005 after 316 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: 4 generations back to K945802 (1995). 10 ancestors in all.
13 later devices descend from it; 3 cite it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040683: Bioderm Sciences Wound Dressing, Bioderm Sciences, Inc. (2004) Summary page 1.
- K945802: Dermagran Wound Cleanser with Zinc, Derma Sciences, Inc. (1995) Summary page 1.
- K040779: Restore Wound Cleanser, Hollister, Inc. (2004) Summary page 1.

## Most influential descendants
- K083042: Wound Flush, Sterile Water & Normal Saline (2008), 7 descendants of its own
- K161311: USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (2016), 2 descendants of its own
- K141660: Nawalution Skin and Wound Cleanser (2014), 2 descendants of its own
- K173276: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP (2018), 1 descendant of its own
- K172486: Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle (2017), 1 descendant of its own

## Indications for use
BioDerm Sciences Wound Spray is intended to cleanse, rinse and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, bums and ulcers (diabetic, venous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid). BioDern Sciences Wound Spray is intendedlo clean, rinse and externally manage skin wounds such as minor lacerations, minor cuts, minor bums and abrasions.

Source page: https://510kreport.com/device/K042084
Methodology: https://510kreport.com/methodology