Class Class II
MilkMate Breast Pump (K223084)
Description
MilkMate Breast Pump by Milkmate Products, Inc., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223084
Clearance Date2023-03-16
Clearance TypeTraditional
Product CodeHGX
Regulation Number884.5160
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223084
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MilkMate Breast Pump (K223084) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201152 | Electric Breast Pump | Guangdong Horigen Mother & Baby Pro... | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241705 | MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single... | Milkmate Products, Inc. | 2024 |
Trace the full predicate network for K223084
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.