Cleared Traditional

K001167 - OPI BAND (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001167 · Orthomerica Products, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
88d
Days
Class 2
Risk

K001167 is an FDA 510(k) clearance for the OPI BAND. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Orthomerica Products, Inc. (Washington, US). The FDA issued a Cleared decision on July 7, 2000 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthomerica Products, Inc. devices

Submission Details

510(k) Number K001167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date July 07, 2000
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K001167.
Talee, Talee PostOp
K241957 · Invent Medical USA, LLC · Aug 2024
Talee, Talee PostOp
K230444 · Invent Medical USA, LLC · Jun 2023
STARband 3D
K223238 · Orthomerica Products, Inc. · Apr 2023
Talee, Talee PostOP
K220681 · Invent Medical USA, LLC · Sep 2022
Hanger Cranial Band 3D
K203134 · Symbion Logistics, LLC · Jul 2022
MyCRO Band
K213587 · Otto Bock Healthcare LP · Jun 2022