Cleared Traditional

HydroMARK Breast Biopsy Site Marker (K212158) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212158 · Devicor Medical Products, Inc. · General & Plastic Surgery device
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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

Submission Details

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.

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 47
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