De Novo · Granted
GrantedMiris Human Milk Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miris AB · QEI Breast Milk Macronutrients Test System
Granted on Dec 21, 2018 as a new device type through De Novo after a 312-day review. 2 later devices descend from it.
- Decided
- Dec 21, 2018
- Review
- 312 days
- Class
- Class II
- Product code
- QEI
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180007 | Miris Human Milk Analyzer | Miris AB | 2018 | — |
| +1 | K234088 | Emily's Care Nourish Test System (Model 1) | Lactation Lab, Inc. | 2024 | — |
| +1 | K223085 | Miris Human Milk Analyzer (HMA) | Miris AB | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEI device
- #1 K234088 Emily's Care Nourish Test System (Model 1)score 7.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K234088 (Lactation Lab, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QEI devicesQEI Breast Milk Macronutrients Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QEI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEI
Too few QEI 510(k)s in any year since 2007 to give a median.
Recalls per year · QEI
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEI
No MAUDE report names QEI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180007 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180007: Miris Human Milk Analyzer.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180007
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026