# K083042: Wound Flush, Sterile Water & Normal Saline

- Pathway: 510(k) (Traditional)
- Applicant: Nurse Assist, Inc.
- Decided: Dec 18, 2008 after 65 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945802 (1995). 16 ancestors in all.
7 later devices descend from it; 6 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)
- K003402: Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation, Welcon, Inc. (2001) Summary page 1.
- K060113: Dermacyn Wound Care, Oculus Innovative Sciences, Inc. (2006) Summary page 1.
- K070463: Revera Wound Care, Model MDW0060, Revalesio Corporation (2008) Summary page 1.
- K042084: Bioderm Sciences Wound Healing Spray, Bioderm Sciences, Inc. (2005) Summary page 1.
- (no number) Blairex Wound Wash Saline: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K973784: Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests, Biosite Incorporated (1997). Our reading of the summary gave K973784, FDA’s number for Triage Panel for Drugs of Abuse, Plus Tricyclic… (Biosite Incorporated). Its FDA name has none of the distinctive words the summary uses for the device it names, “Welcon Sterile Water and Sterile 0.9% Normal Saline”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- 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
- K243001: Sterile Water USP and Sterile 0.9% Normal Saline USP (2025), 0 descendants of its own
- K181423: AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (2018), 0 descendants of its own

## Recalls of this device
- Nov 6, 2023 · Class I · Z-0511-2024: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product
- Nov 6, 2023 · Class I · Z-0513-2024: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product

## Indications for use
For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

Source page: https://510kreport.com/device/K083042
Methodology: https://510kreport.com/methodology