Cleared Traditional

K230444 - Talee

K230444 is an FDA 510(k) clearance for Talee, manufactured by Invent Medical USA, LLC. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K230444 · Invent Medical USA, LLC · Neurology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K230444

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.

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 8
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
K203134 · Symbion Logistics, LLC · Jul 2022
MyCRO Band
K213587 · Otto Bock Healthcare LP · Jun 2022
SnugKap
K193383 · Headstart, Ltd. · Jun 2021