Cleared Traditional

NORAPAD PLAIN (K014268) - FDA 510(k) Clearance

Also marketed or referenced as:
NORAPAD TA

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014268 · Perlei Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
90d
Days
Class 2
Risk

K014268 is an FDA 510(k) clearance for the NORAPAD PLAIN. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Perlei Medical, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on March 27, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - 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 Perlei Medical, Inc. devices

Submission Details

510(k) Number K014268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2001
Decision Date March 27, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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.