Cleared Traditional

K132264 - PRIMADO2 TOTAL SURGICAL SYSTEM

K132264 is an FDA 510(k) clearance for PRIMADO2 TOTAL SURGICAL SYSTEM, manufactured by Nakanishi, Inc.. The device is a Class 2 Neurology device with product code HBC cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K132264 · Nakanishi, Inc. · Neurology device
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Dec 2013
Decision
148d
Days
Class 2
Risk

K132264 is an FDA 510(k) clearance for the PRIMADO2 TOTAL SURGICAL SYSTEM. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on December 17, 2013 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - 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 Nakanishi, Inc. devices

FDA 510(k) Submission Details - K132264

510(k) Number K132264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2013
Decision Date December 17, 2013
Days to Decision 148 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
At panel average
Panel avg: 148d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBC Device Classification - Class 2, Special Controls

Product Code HBC Motor, Drill, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4360
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 - HBC Motor, Drill, Electric

All 18
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