Cleared Traditional

K203097 - HydroMARK Breast Biopsy Site Markers

K203097 is the FDA 510(k) clearance for HydroMARK Breast Biopsy Site Markers by Devicor Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K203097 · Devicor Medical Products, Inc. · General & Plastic Surgery device
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Dec 2020
Decision
63d
Days
Class 2
Risk

K203097 is an FDA 510(k) clearance for the HydroMARK Breast Biopsy Site Markers. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 16, 2020 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Devicor Medical Products, Inc. devices

Submission Details

510(k) Number K203097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2020
Decision Date December 16, 2020
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 Peers - NEU Marker, Radiographic, Implantable

All 55
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K203097.
MOLLI
K210600 · Molli Surgical, Inc. · Apr 2021
HydroMARK Breast Biopsy Site Marker
K210752 · Devicor Medical Products, Inc. · Apr 2021
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
K201863 · Somatex Medical Technologies GmbH · Feb 2021
C4 Fiducial Marker
K192771 · C4 Imaging, LLC · Oct 2020
RFID Localization System
K193189 · Health Beacons, Inc. · May 2020
EasyMark Tissue Marker
K183503 · Inrad, Inc. · Oct 2019