Cleared Traditional

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

K240527 is an FDA 510(k) clearance for HydroMARK Plus Breast Biopsy Site Marke..., 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 138-day FDA review.

K240527 · Devicor Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K240527

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
23d slower than avg
Panel avg: 115d · This submission: 138d
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 92
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K240527.
MOLLI 2 System
K234149 · Molli Surgical, Inc. · Sep 2024
MOLLI 2 System
K240042 · Molli Surgical, Inc. · Sep 2024
OneMark
K241762 · View Point Medical · Sep 2024
Magseed Pro Magnetic Marker System
K232865 · Endomagnetics Ltd., · Jun 2024
SCOUT MD Surgical Guidance System
K231468 · Merit Medical System, Inc. · Feb 2024
SchurSign Tissue Marker
K230836 · Surgmark GmbH · Jan 2024