Cleared Traditional

K083112 - PRIMADO

K083112 is an FDA 510(k) clearance for PRIMADO, 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 190-day FDA review.

K083112 · Nakanishi, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
190d
Days
Class 2
Risk

K083112 is an FDA 510(k) clearance for the PRIMADO. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Washington, US). The FDA issued a Cleared decision on April 29, 2009 after a review of 190 days - an extended review cycle.

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 - K083112

510(k) Number K083112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2008
Decision Date April 29, 2009
Days to Decision 190 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
42d slower than avg
Panel avg: 148d · This submission: 190d
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 21
Devices cleared under the same product code (HBC) and FDA review panel - the closest regulatory comparables to K083112.
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MICROPOWER HAND PIECE HIGH SPEED DRILL
K060260 · Linvatec Corp. · Apr 2006
MICROSPEED UNI MOTOR SYSTEM
K053526 · Aesculap, Inc. · Jan 2006