Cleared Traditional

K000861 - CRANIOCAP

K000861 is an FDA 510(k) clearance for CRANIOCAP, manufactured by Gillette Children'S Specialty Healthcare. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K000861 · Gillette Children'S Specialty Healthcare · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
227d
Days
Class 2
Risk

K000861 is an FDA 510(k) clearance for the CRANIOCAP. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Gillette Children'S Specialty Healthcare (Eagan, US). The FDA issued a Cleared decision on October 30, 2000 after a review of 227 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5970 - 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 Gillette Children'S Specialty Healthcare devices

FDA 510(k) Submission Details - K000861

510(k) Number K000861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2000
Decision Date October 30, 2000
Days to Decision 227 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
78d slower than avg
Panel avg: 149d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVA Device Classification - Class 2, Special Controls

Product Code MVA Orthosis, Cranial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
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 - MVA Orthosis, Cranial

All 42
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K000861.
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
K003630 · Danmar Products, Inc. · May 2001
CRANIAL MOLDING ORTHOSIS
K010273 · Orthotic Solutions, Inc. · Apr 2001
HANGER CRANIAL BAND
K001669 · Hanger Orthopedic Group, Inc. · Dec 2000
OPI BAND
K001167 · Orthomerica Products, Inc. · Jul 2000
DYNAMIC ORTHOTIC CRANIOPLASTY BAND
DEN980001 · Cranial Technologies, Inc. · May 1998