# K935060: Brennen Medical Sterile Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, Inc.
- Decided: Jan 10, 1994 after 82 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972185: 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride (1998), 32 descendants of its own
- 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

Source page: https://510kreport.com/device/K935060
Methodology: https://510kreport.com/methodology