# K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553

- Pathway: 510(k) (Traditional)
- Applicant: Blairex Laboratories, Inc.
- Decided: Dec 29, 2008 after 46 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: 5 generations back to K914579 (1992). 34 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073610: Elta Advanced Wound Wash, Swiss American Products, Inc. (2008) Summary page 2.
- K040683: Bioderm Sciences Wound Dressing, Bioderm Sciences, Inc. (2004) Summary page 2.
- K063063: Silvacide Skin & Wound Moisturizing Solution, Medical Molecular Therapuetics, LLC (2007) Summary page 2.
- K063069: Silvaklenz Skin and Wound Clenser Solution, Medical Molecular Therapuetics, LLC (2007) Summary page 2.
- K070463: Revera Wound Care, Model MDW0060, Revalesio Corporation (2008) Summary page 2.
- K040779: Restore Wound Cleanser, Hollister, Inc. (2004) Summary page 2.

## Most influential descendants
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own
- K243415: Granudacyn® Wound Irrigation Solution (2025), 1 descendant of its own
- K213514: Spectricept Skin and Wound Cleanser (2023), 1 descendant of its own

## Indications for use
To cleanse wounds, scrapes, and minor burns.

Source page: https://510kreport.com/device/K083355
Methodology: https://510kreport.com/methodology