Cleared Traditional

K021594 - COPC BAND

K021594 is an FDA 510(k) clearance for COPC BAND, manufactured by Center For Orthotic and Prosthetic Care,Llc. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 547-day FDA review.

K021594 · Center For Orthotic and Prosthetic Care,Llc · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
547d
Days
Class 2
Risk

K021594 is an FDA 510(k) clearance for the COPC BAND. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Center For Orthotic and Prosthetic Care,Llc (Arlington, US). The FDA issued a Cleared decision on November 13, 2003 after a review of 547 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Center For Orthotic and Prosthetic Care,Llc devices

FDA 510(k) Submission Details - K021594

510(k) Number K021594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2002
Decision Date November 13, 2003
Days to Decision 547 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
399d slower than avg
Panel avg: 148d · This submission: 547d
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 18
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K021594.
CRANIAL REMOLDING ORTHOSIS
K111247 · Orthotic Care Services, Llp · Aug 2011
AOI CRANIAL HELMET
K103362 · Advanced Orthopro, Inc. · Apr 2011
CRANIAL HELMET
K041215 · Otto Bock Healthcare LP · Sep 2004
OPI BAND
K001167 · Orthomerica Products, Inc. · Jul 2000
DYNAMIC ORTHOTIC CRANIOPLASTY BAND
DEN980001 · Cranial Technologies, Inc. · May 1998