# DEN180007: Miris Human Milk Analyzer

- Pathway: De Novo (Direct)
- Applicant: Miris AB
- Decided: Dec 21, 2018 after 312 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K234088: Emily's Care Nourish Test System (Model 1) (2024), 0 descendants of its own
- K223085: Miris Human Milk Analyzer (HMA) (2023), 0 descendants of its own

## Indications for use
The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, carbohydrate, and protein 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.

Source page: https://510kreport.com/device/DEN180007
Methodology: https://510kreport.com/methodology