# K972185: 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride

- Pathway: 510(k) (Traditional)
- Applicant: Steripak, Ltd.
- Decided: Mar 5, 1998 after 268 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: 1 generation back to K935060 (1994). 1 ancestor in all.
32 later devices descend from it; 2 cite it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935060: Brennen Medical Sterile Saline Solution, Brennen Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K040683: Bioderm Sciences Wound Dressing (2004), 29 descendants of its own
- 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

## Indications for use
20mL Normal Saline Topical Solution is used for moistening and lubricating absorbent wound dressing prior to removal from the wound area.

Source page: https://510kreport.com/device/K972185
Methodology: https://510kreport.com/methodology