Cleared Traditional

K221961 - HydroMARK Plus Breast Biopsy Site Marker (FDA 510(k) Clearance)

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

K221961 · Devicor Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
373d
Days
Class 2
Risk

K221961 is an FDA 510(k) clearance for the HydroMARK Plus 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 July 13, 2023 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K221961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2022
Decision Date July 13, 2023
Days to Decision 373 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
259d slower than avg
Panel avg: 114d · This submission: 373d
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 109
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K221961.
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape)
K253761 · Devicor Medical Products, Inc. · Jan 2026
MOLLI 2 System
K253888 · Stryker Endoscopy · Dec 2025
SCOUT MD Surgical Guidance System
K252892 · Merit Medical Systems, Inc. · Dec 2025
VizMark Preloaded Tissue Marker Device (VM-0001)
K251989 · Breast-Med, Inc. · Dec 2025
MammoSTAR Biopsy Site Identifier
K251748 · Carbon Medical Technologies, Inc. · Jul 2025
UltraCor™ Twirl™ Breast Tissue Marker
K243642 · Bard Peripheral Vascular, Inc. · Mar 2025