# K223085: Miris Human Milk Analyzer (HMA)

- Pathway: 510(k) (Traditional)
- Applicant: Miris AB
- Decided: Sep 29, 2023 after 364 days
- Product code: QEI (Breast Milk Macronutrients Test System)
- Device class: 2
- Regulation: 21 CFR 862.1493
- 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 DEN180007 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180007: Miris Human Milk Analyzer, Miris AB (2018) Summary page 4.

## Indications for use
The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories. The Miris HMA is also intended for use by personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks, for the purpose of labeling milk donations and in the processing of milk donations.

Source page: https://510kreport.com/device/K223085
Methodology: https://510kreport.com/methodology