Cleared Traditional

K253772 - Velocity Alpha MR High Speed Surgical Drill System

K253772 is an FDA 510(k) clearance for Velocity Alpha MR High Speed Surgical D..., manufactured by Adeor Medical AG. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K253772 · Adeor Medical AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
100d
Days
Class 2
Risk

K253772 is an FDA 510(k) clearance for the Velocity Alpha MR High Speed Surgical Drill System. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Adeor Medical AG (Valley, DE). The FDA issued a Cleared decision on March 6, 2026 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - 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 Adeor Medical AG devices

FDA 510(k) Submission Details - K253772

510(k) Number K253772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2025
Decision Date March 06, 2026
Days to Decision 100 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
48d faster than avg
Panel avg: 148d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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 - HBB Motor, Drill, Pneumatic

All 22
Devices cleared under the same product code (HBB) and FDA review panel - the closest regulatory comparables to K253772.
ELAN 4 Air Motor System
K172907 · Aesculap, Inc. · Nov 2018
Medtronic Legend Pneumatic
K163182 · Medtronic Powered Surgical Solutions · Mar 2017
Stryker Maestro Air Motors
K150801 · Stryker Corporation · May 2015
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · Medtronic Sofamor Danek · Aug 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
K093361 · Synthes (Usa) · Apr 2010
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K061297 · The Anspach Effort, Inc. · Jan 2007