Cleared Traditional

K083112 - PRIMADO

K083112 is the FDA 510(k) clearance for PRIMADO by Nakanishi, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

Device Classification

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 15
Devices cleared under the same product code (HBC) and FDA review panel - the closest regulatory comparables to K083112.
ELAN 4 Motor System
K152960 · Aesculap, Inc. · Jul 2016
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
K133604 · The Anspach Effort, Inc. · Jan 2014
PRIMADO2 TOTAL SURGICAL SYSTEM
K132264 · Nakanishi, Inc. · Dec 2013
MICROPOWER HAND PIECE HIGH SPEED DRILL
K060260 · Linvatec Corp. · Apr 2006
MICROSPEED UNI MOTOR SYSTEM
K053526 · Aesculap, Inc. · Jan 2006
ANSPACH EMAX DRILL SYSTEM
K011444 · The Anspach Effort, Inc. · Aug 2001