Cleared Traditional

K061725 - STRYKER ARIA PNEUMATIC SYSTEM

K061725 is the FDA 510(k) clearance for STRYKER ARIA PNEUMATIC SYSTEM by Stryker Instruments. It is a Class 2 Neurology device (product code HBB) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K061725 · Stryker Instruments · Neurology device
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Oct 2006
Decision
129d
Days
Class 2
Risk

K061725 is an FDA 510(k) clearance for the STRYKER ARIA PNEUMATIC SYSTEM. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 26, 2006 after a review of 129 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 Stryker Instruments devices

Submission Details

510(k) Number K061725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date October 26, 2006
Days to Decision 129 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
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
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