Cleared Traditional

K251517 - Encora X1 (FDA 510(k) Clearance)

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

K251517 · Encora, Inc. · Neurology device
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Feb 2026
Decision
265d
Days
Class 2
Risk

K251517 is an FDA 510(k) clearance for the Encora X1. Classified as External Upper Limb Tremor Stimulator (product code QBC), Class II - Special Controls.

Submitted by Encora, Inc. (Boston, US). The FDA issued a Cleared decision on February 5, 2026 after a review of 265 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5897 - 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 Encora, Inc. devices

Submission Details

510(k) Number K251517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2025
Decision Date February 05, 2026
Days to Decision 265 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
117d slower than avg
Panel avg: 148d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBC External Upper Limb Tremor Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5897
Definition An External Upper Limb Tremor Stimulator Is A Prescription Device Which Is Placed Externally On The Upper Limb And Designed To Aid In Tremor Symptom Relief Of The Upper Limb.
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 - QBC External Upper Limb Tremor Stimulator

All 8
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