Cleared Traditional

K994022 - PARALLAX CRANIOSET

K994022 is an FDA 510(k) clearance for PARALLAX CRANIOSET, manufactured by Parallax Medical, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K994022 · Parallax Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
279d
Days
Class 2
Risk

K994022 is an FDA 510(k) clearance for the PARALLAX CRANIOSET. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Parallax Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 31, 2000 after a review of 279 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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 Parallax Medical, Inc. devices

FDA 510(k) Submission Details - K994022

510(k) Number K994022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date August 31, 2000
Days to Decision 279 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
131d slower than avg
Panel avg: 148d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 - GXP Methyl Methacrylate For Cranioplasty

All 26
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K994022.
BONESOURCE HAC
K021440 · Stryker Instruments · Aug 2002
FAST SET PUTTY
K012589 · Synthes (Usa) · Feb 2002
MODIFICATION TO: INJECTABLE MIMIX
K012569 · Biomet, Inc. · Dec 2001
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
K873689 · Dentsply Intl. · Oct 1987