Cleared Special

K150801 - Stryker Maestro Air Motors

K150801 is an FDA 510(k) clearance for Stryker Maestro Air Motors, manufactured by Stryker Corporation. The device is a Class 2 Neurology device with product code HBB cleared through the Special 510(k) pathway after a 57-day FDA review.

K150801 · Stryker Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
57d
Days
Class 2
Risk

K150801 is an FDA 510(k) clearance for the Stryker Maestro Air Motors. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on May 22, 2015 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150801

510(k) Number K150801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2015
Decision Date May 22, 2015
Days to Decision 57 days
Submission Type Special
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
92d faster than avg
Panel avg: 149d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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 26
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K150801 · Stryker Maestro Air Motors
Download PDF FDA Summary Stryker Corporation