Cleared Traditional

SAFETOUCH (K022861) - FDA 510(k) Clearance

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

K022861 · Rusin Medical Devices · Obstetrics & Gynecology device
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Nov 2002
Decision
90d
Days
Class 2
Risk

K022861 is an FDA 510(k) clearance for the SAFETOUCH. Classified as Sheet, Recording, Breast Examination (product code NHM), Class II - Special Controls.

Submitted by Rusin Medical Devices (Anoka, US). The FDA issued a Cleared decision on November 26, 2002 after a review of 90 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 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.

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Submission Details

510(k) Number K022861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2002
Decision Date November 26, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHM Sheet, Recording, Breast Examination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2990
Definition This Recording Sheet Is Intended To For Clinicians To Mark The Locationof A Palpable Breast Lump Identified By A Clinical Breast Examination.
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.