Cleared Traditional

K231875 - Vaginal Tactile Ultrasound Imager (FDA 510(k) Clearance)

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

K231875 · Advanced Tactile Imaging, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
241d
Days
Class 2
Risk

K231875 is an FDA 510(k) clearance for the Vaginal Tactile Ultrasound Imager. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Advanced Tactile Imaging, Inc. (Ewing, US). The FDA issued a Cleared decision on February 22, 2024 after a review of 241 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1425 - 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.

View all Advanced Tactile Imaging, Inc. devices

Submission Details

510(k) Number K231875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2023
Decision Date February 22, 2024
Days to Decision 241 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
81d slower than avg
Panel avg: 160d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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 Peers - HIR Perineometer

All 64
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