Cleared Traditional

K201426 - MyCRO Band (FDA 510(k) Clearance)

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

K201426 · Otto Bock Healthcare LP · Neurology device
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Mar 2021
Decision
301d
Days
Class 2
Risk

K201426 is an FDA 510(k) clearance for the MyCRO Band. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Otto Bock Healthcare LP (Salt Lake City, US). The FDA issued a Cleared decision on March 26, 2021 after a review of 301 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Otto Bock Healthcare LP devices

Submission Details

510(k) Number K201426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2020
Decision Date March 26, 2021
Days to Decision 301 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
153d slower than avg
Panel avg: 148d · This submission: 301d
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 Consultant

Strategic Quality Solutions, LLC
Adrienne Von Foller

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MVA Orthosis, Cranial

All 42
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K201426.
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