Cleared Traditional

K241748 - Intimate Rose Vaginal Dilators (FDA 510(k) Clearance)

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

K241748 · Plus EV Holdings Dba Intimate Rose · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
57d
Days
Class 2
Risk

K241748 is an FDA 510(k) clearance for the Intimate Rose Vaginal Dilators. Classified as Dilator, Vaginal (product code HDX), Class II - Special Controls.

Submitted by Plus EV Holdings Dba Intimate Rose (North Kansas City, US). The FDA issued a Cleared decision on August 14, 2024 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Plus EV Holdings Dba Intimate Rose devices

Submission Details

510(k) Number K241748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2024
Decision Date August 14, 2024
Days to Decision 57 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 160d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Third Party Review Group, LLC
Dave Yungvirt

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 K241748.
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
Milli Vaginal Dilator
K211959 · Materna Medical · Dec 2021