Cleared Traditional

K211959 - Milli Vaginal Dilator (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211959 · Materna Medical · Obstetrics & Gynecology device
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Dec 2021
Decision
160d
Days
Class 2
Risk

K211959 is an FDA 510(k) clearance for the Milli Vaginal Dilator. Classified as Dilator, Vaginal (product code HDX), Class II - Special Controls.

Submitted by Materna Medical (Mountain View, US). The FDA issued a Cleared decision on December 1, 2021 after a review of 160 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3900 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K211959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2021
Decision Date December 01, 2021
Days to Decision 160 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 160d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDX Dilator, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Experien Group, LLC
Valerie Defiesta-Ng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HDX Dilator, Vaginal

All 8
Devices cleared under the same product code (HDX) and FDA review panel - the closest regulatory comparables to K211959.
Intimate Rose Vaginal Dilators
K241748 · Plus EV Holdings Dba Intimate Rose · Aug 2024
Hope&Her Vaginal Dilators
K233689 · Lujena, Inc. · May 2024
Hope&Her Vaginal Dilators
K222492 · Lujena, Inc. · Jun 2023
Intimate Rose Vaginal Dilators
K231430 · Plus EV Holdings Dba Intimate Rose · Jun 2023
Milli Vaginal Dilator
K220035 · Materna Medical · Feb 2023