Cleared Traditional

K190689 - SignalMark Breast Marker

K190689 is the FDA 510(k) clearance for SignalMark Breast Marker by View Point Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K190689 · View Point Medical, Inc. · General & Plastic Surgery device
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Aug 2019
Decision
149d
Days
Class 2
Risk

K190689 is an FDA 510(k) clearance for the SignalMark Breast Marker. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by View Point Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 14, 2019 after a review of 149 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all View Point Medical, Inc. devices

Submission Details

510(k) Number K190689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2019
Decision Date August 14, 2019
Days to Decision 149 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Acknowledge Regulatory Strategies, LLC
Michelle Rubin-Onur

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 - NEU Marker, Radiographic, Implantable

All 55
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K190689.
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K181692 · Health Beacons, Inc. · Sep 2018