Cleared Traditional

K142238 - MAYFIELD Skull Clamp

K142238 is the FDA 510(k) clearance for MAYFIELD Skull Clamp by Integra LifeSciences Corporation. It is a Class 2 Neurology device (product code HBL) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K142238 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
103d
Days
Class 2
Risk

K142238 is an FDA 510(k) clearance for the MAYFIELD Skull Clamp. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on November 24, 2014 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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 Integra LifeSciences Corporation devices

Submission Details

510(k) Number K142238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2014
Decision Date November 24, 2014
Days to Decision 103 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
45d faster than avg
Panel avg: 148d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 - HBL Holder, Head, Neurosurgical (skull Clamp)

All 21
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K142238.
DORO LUCENT® iXI and iMRI Headrest System
K191740 · Pro-Med Instruments GmbH · Feb 2020
Arcus Head Fixation Frame
K191701 · Mri Interventions, Inc. · Nov 2019
DORO QR3 XTom Headholder System
K191979 · Pro-Med Instruments GmbH · Oct 2019
STERILE RADIOLUCENT SKULL PINS
K122225 · Brainlab AG · Apr 2013
MAYFIELD INFINITY XR2 SKULL CLAMP
K130389 · Integra LifeSciences Corporation · Apr 2013
MAYFIELD SKULL CLAMP
K120633 · Integra LifeSciences Corporation · May 2012