Cleared Traditional

K240527 - HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (FDA 510(k) Clearance)

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

K240527 · Devicor Medical Products, Inc. · General & Plastic Surgery device
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Jul 2024
Decision
138d
Days
Class 2
Risk

K240527 is an FDA 510(k) clearance for the HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6). 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 10, 2024 after a review of 138 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 Devicor Medical Products, Inc. devices

Submission Details

510(k) Number K240527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2024
Decision Date July 10, 2024
Days to Decision 138 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
24d slower than avg
Panel avg: 114d · This submission: 138d
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 K240527.
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