Cleared Traditional

SureTouch Mobile Pressure Mapping System (K181672) - FDA 510(k) Clearance

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

K181672 · Sure, Inc. · Obstetrics & Gynecology device
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Jun 2019
Decision
368d
Days
Class 2
Risk

K181672 is an FDA 510(k) clearance for the SureTouch Mobile Pressure Mapping System. Classified as System, Documentation, Breast Lesion (product code NKA), Class II - Special Controls.

Submitted by Sure, Inc. (Palos Verdes Estates, US). The FDA issued a Cleared decision on June 28, 2019 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2990 - 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 Sure, Inc. devices

Submission Details

510(k) Number K181672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date June 28, 2019
Days to Decision 368 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
208d slower than avg
Panel avg: 160d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

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Laurence Harvey

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.