Class Class II
Milli Vaginal Dilator (K220035)
Description
Milli Vaginal Dilator by Materna Medical, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220035
Clearance Date2023-02-27
Clearance TypeTraditional
Product CodeHDX
Regulation Number884.3900
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220035
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. Milli Vaginal Dilator (K220035) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211959 | Milli Vaginal Dilator | Materna Medical | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2024 |
Trace the full predicate network for K220035
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.