# K945000: Multidex Hydrophilic Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Lange Medical Products, Inc.
- Decided: Nov 17, 1994 after 35 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K970266: Kendall Hydrophilic Powder Wound Dressing (1997), 0 descendants of its own

## Recalls of this device
- Jan 19, 2004 · Not classified · Z-0544-04: Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.

Source page: https://510kreport.com/device/K945000
Methodology: https://510kreport.com/methodology