Cleared Traditional

K241957 - Talee, Talee PostOp (FDA 510(k) Clearance)

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

K241957 · Invent Medical USA, LLC · Neurology device
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Aug 2024
Decision
58d
Days
Class 2
Risk

K241957 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 August 30, 2024 after a review of 58 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 Invent Medical USA, LLC devices

Submission Details

510(k) Number K241957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2024
Decision Date August 30, 2024
Days to Decision 58 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
90d faster than avg
Panel avg: 148d · This submission: 58d
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 K241957.
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
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MyCRO Band
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K193383 · Headstart, Ltd. · Jun 2021