Cleared Traditional

K252696 - LEGACY

K252696 is an FDA 510(k) clearance for LEGACY, manufactured by Phasor Health, LLC. The device is a Class 2 Neurology device with product code HBG cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K252696 · Phasor Health, LLC · Neurology device
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Nov 2025
Decision
86d
Days
Class 2
Risk

K252696 is an FDA 510(k) clearance for the LEGACY. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Phasor Health, LLC (Houston, US). The FDA issued a Cleared decision on November 21, 2025 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phasor Health, LLC devices

FDA 510(k) Submission Details - K252696

510(k) Number K252696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2025
Decision Date November 21, 2025
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBG Device Classification - Class 2, Special Controls

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
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 Neurology devices follow this clearance model.

Regulatory Peers - HBG Drills, Burrs, Trephines & Accessories (manual)

Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K252696.
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K904283 · Pudenz-Schulte Medical Research Corp. · Oct 1990
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K892531 · Zinnanti Surgical Instruments, Inc. · May 1989