Cleared Traditional

K212158 - HydroMARK Breast Biopsy Site Marker

K212158 is an FDA 510(k) clearance for HydroMARK Breast Biopsy Site Marker, manufactured by Devicor Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K212158 · Devicor Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
283d
Days
Class 2
Risk

K212158 is an FDA 510(k) clearance for the HydroMARK Breast Biopsy Site Marker. 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 April 21, 2022 after a review of 283 days - an extended review 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: 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 Devicor Medical Products, Inc. devices

FDA 510(k) Submission Details - K212158

510(k) Number K212158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date April 21, 2022
Days to Decision 283 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
168d slower than avg
Panel avg: 115d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEU Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K212158.
HydroMARK Plus Breast Biopsy Site Marker
K221961 · Devicor Medical Products, Inc. · Jul 2023
Sentimag System
K222832 · Endomagnetics Ltd., · Jan 2023
MOLLI 2
K223107 · Molli Surgical, Inc. · Jan 2023
SCOUT BX Delivery System
K212882 · Merit Medical Systems, Inc. · Apr 2022
MOLLI
K210600 · Molli Surgical, Inc. · Apr 2021
HydroMARK Breast Biopsy Site Marker
K210752 · Devicor Medical Products, Inc. · Apr 2021