# K143310: MoisturemeterD

- Pathway: 510(k) (Traditional)
- Applicant: Delfin Technologies, Ltd.
- Decided: Nov 19, 2015 after 366 days
- Product code: OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904109 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080825: Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400, Impedimed Pty, Ltd. (2008) Summary page 4.

## Most influential descendants
- K220557: MoistureMeterD Compact, LymphScanner (2022), 0 descendants of its own

## Indications for use
Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.

Source page: https://510kreport.com/device/K143310
Methodology: https://510kreport.com/methodology