Cleared Abbreviated

iBreastExam (K190575) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K190575 · Ue Lifesciences, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
132d
Days
Class 2
Risk

K190575 is an FDA 510(k) clearance for the iBreastExam. Classified as System, Documentation, Breast Lesion (product code NKA), Class II - Special Controls.

Submitted by Ue Lifesciences, Inc. (Philadelphia, US). The FDA issued a Cleared decision on July 16, 2019 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2990 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ue Lifesciences, Inc. devices

Submission Details

510(k) Number K190575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2019
Decision Date July 16, 2019
Days to Decision 132 days
Submission Type Abbreviated
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
28d faster than avg
Panel avg: 160d · This submission: 132d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NKA System, Documentation, Breast Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2990
Definition A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam.
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.