Cleared Traditional

K222492 - Hope&Her Vaginal Dilators (FDA 510(k) Clearance)

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

K222492 · Lujena, Inc. · Obstetrics & Gynecology device
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Jun 2023
Decision
314d
Days
Class 2
Risk

K222492 is an FDA 510(k) clearance for the Hope&Her Vaginal Dilators. Classified as Dilator, Vaginal (product code HDX), Class II - Special Controls.

Submitted by Lujena, Inc. (El Cajon, US). The FDA issued a Cleared decision on June 27, 2023 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Lujena, Inc. devices

Submission Details

510(k) Number K222492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2022
Decision Date June 27, 2023
Days to Decision 314 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
154d slower than avg
Panel avg: 160d · This submission: 314d
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

Matrix Medical Consulting, Inc.
Alan Donald

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 K222492.
Intimate Rose Vaginal Dilators
K241748 · Plus EV Holdings Dba Intimate Rose · Aug 2024
Hope&Her Vaginal Dilators
K233689 · Lujena, Inc. · May 2024
Intimate Rose Vaginal Dilators
K231430 · Plus EV Holdings Dba Intimate Rose · Jun 2023
Milli Vaginal Dilator
K220035 · Materna Medical · Feb 2023
Milli Vaginal Dilator
K211959 · Materna Medical · Dec 2021