510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223085Substantially Equivalent

Miris Human Milk Analyzer (HMA)

Miris AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223085 is the FDA 510(k) clearance record for Miris Human Milk Analyzer (HMA), a class II device, cleared for Miris AB on under FDA product code QEI (Breast Milk Macronutrients Test System). FDA's definition for product code QEI reads: "A breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to...". FDA records list 2 510(k) clearances for Miris AB, from to . As of , FDA records show no recalls naming K223085.

Clearance record

Decision date
Received
(364 days to decision)
Product code
QEI Breast Milk Macronutrients Test System
Regulation
21 CFR 862.1493
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Miris AB Danmarksgatan 26, Uppsala, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEI

Trailing 12 months

FDA records hold no clearances under product code QEI in the trailing twelve months.

FDA records show no clearances under product code QEI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260