510(k) · Cleared
ClearedMiris Human Milk Analyzer (HMA)
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
Cleared on Sep 29, 2023 as substantially equivalent to DEN180007 (Miris AB, 2018) after a 364-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Sep 29, 2023
- Review
- 364 days
- Class
- Class II
- Product code
- QEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180007 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180007 Miris Human Milk AnalyzerMiris AB · 2018
- This deviceK223085 Miris Human Milk Analyzer (HMA)Miris AB · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180007 | Miris Human Milk Analyzer | Miris AB | 2018 | — |
| 0 (this device) | K223085 | Miris Human Milk Analyzer (HMA) | Miris AB | 2023 | — |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180007 | Miris Human Milk AnalyzerSummary page 4…e: Breast milk macronutrient test system Regulatory Class: Class II Regulation Number: 21 CFR 862.1493 Product Code: QEI Predicate Devices Miris Human Milk Analyzer DEN180007 Device Description The Miris Human Milk Analyzer (HMA) includes a mid-infrared (mid-IR) spectroscopy system and a man-machine i… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN180007.
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. 2023, 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, 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…
Read the full statement (112 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223085: Miris Human Milk Analyzer (HMA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223085
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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