Cleared Traditional

K014268 - NORAPAD PLAIN

Also marketed or referenced as:
NORAPAD TA

K014268 is an FDA 510(k) clearance for NORAPAD PLAIN, manufactured by Perlei Medical, Inc.. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K014268

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.

HBA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HBA Neurosurgical Paddie

All 12
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K014268.
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · American Surgical Company, LLC · Jun 2013
DELICOT
K121822 · American Surgical Company, LLC · Sep 2012
AESCULAP NEURO PATTIES
K062406 · Aesculap, Inc. · Sep 2006
PACIFIC SURGICAL PATTIES
K993019 · V. Mueller Neuro/Spine · Mar 2000
ULTRACELL NEURO SPONGES
K973083 · Ultracell Medical Technologies, Inc. · Dec 1997
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
K962807 · American Surgical Sponges · May 1997