Cleared Traditional

PRIMADO SURGICAL DRILL (K080722) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080722 · Nakanishi, Inc. · Ear, Nose, Throat device
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Sep 2008
Decision
188d
Days
Class 2
Risk

K080722 is an FDA 510(k) clearance for the PRIMADO SURGICAL DRILL. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Washington, US). The FDA issued a Cleared decision on September 17, 2008 after a review of 188 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K080722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2008
Decision Date September 17, 2008
Days to Decision 188 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 89d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 90
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K080722.
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