Cleared Traditional

K252060 - GREEN

K252060 is an FDA 510(k) clearance for GREEN, manufactured by Phasor Health, LLC. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K252060 · Phasor Health, LLC · Neurology device
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Oct 2025
Decision
122d
Days
Class 2
Risk

K252060 is an FDA 510(k) clearance for the GREEN. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Phasor Health, LLC (Houston, US). The FDA issued a Cleared decision on October 31, 2025 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phasor Health, LLC devices

FDA 510(k) Submission Details - K252060

510(k) Number K252060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2025
Decision Date October 31, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 41
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K252060.
Surgify Halo (54.085.SHD.U1)
K253627 · Surgify Medical OY · Mar 2026
Hubly Drill (H100)
K250815 · Hubly, Inc. · Nov 2025
UniBur
K252662 · Nakanishi, Inc. · Sep 2025
Surgify Halo (54.085.SHD.H1)
K251433 · Surgify Medical OY · Jun 2025
Surgify Halo (54.085.SHD.H1)
K250380 · Surgify Medical OY · Mar 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
K250374 · Stryker Instruments · Mar 2025