# K946245: Tielle* Hydropolymer Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson International
- Decided: Apr 11, 1995 after 110 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.
34 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983173: Biatain Foam Adhesive Dressing (1998), 33 descendants of its own
- K022416: Contreet Foam Adhesive/Non-Adhesive (2003), 32 descendants of its own
- K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) (2004), 17 descendants of its own
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (2010), 11 descendants of its own
- K062559: Urgocell AG Antimicrobial Wound Dressing with Silver (2007), 6 descendants of its own

Source page: https://510kreport.com/device/K946245
Methodology: https://510kreport.com/methodology