Cleared Traditional

K230444 - Talee, Talee PostOp (FDA 510(k) Clearance)

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

K230444 · Invent Medical USA, LLC · Neurology device
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Jun 2023
Decision
121d
Days
Class 2
Risk

K230444 is an FDA 510(k) clearance for the Talee, Talee PostOp. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Invent Medical USA, LLC (Warminster, US). The FDA issued a Cleared decision on June 22, 2023 after a review of 121 days - within the typical 510(k) review window.

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 Invent Medical USA, LLC devices

Submission Details

510(k) Number K230444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date June 22, 2023
Days to Decision 121 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
27d faster than avg
Panel avg: 148d · This submission: 121d
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 K230444.
Talee, Talee PostOp
K241957 · Invent Medical USA, LLC · Aug 2024
STARband 3D
K223238 · Orthomerica Products, Inc. · Apr 2023
Talee, Talee PostOP
K220681 · Invent Medical USA, LLC · Sep 2022
Hanger Cranial Band 3D
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MyCRO Band
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SnugKap
K193383 · Headstart, Ltd. · Jun 2021