# K980117: Nuvo Barrier Film

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Development Co.
- Decided: Dec 18, 1998 after 339 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
Longest line of descent: 1 generation back to K955103 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955103: 3M NO Sting Barrier Film, 3M Medical Products Group (1996) Summary page 1.

## Most influential descendants
- K042955: Cuticover Skin Barrier Device (2006), 0 descendants of its own

## Indications for use
Skin barrier for protection against the detrimental effects of moisture, urine, or feces.

Source page: https://510kreport.com/device/K980117
Methodology: https://510kreport.com/methodology