Cleared Traditional

K221589 - Starly pad

K221589 is an FDA 510(k) clearance for Starly pad, manufactured by Shenzhen Xingyuanli Technology Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K221589 · Shenzhen Xingyuanli Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
296d
Days
Class 2
Risk

K221589 is an FDA 510(k) clearance for the Starly pad. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Shenzhen Xingyuanli Technology Co., Ltd. (Zhezhen, CN). The FDA issued a Cleared decision on March 24, 2023 after a review of 296 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Shenzhen Xingyuanli Technology Co., Ltd. devices

FDA 510(k) Submission Details - K221589

510(k) Number K221589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2022
Decision Date March 24, 2023
Days to Decision 296 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
148d slower than avg
Panel avg: 148d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 194
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K221589.
Conductive carbon film electrode
K231164 · Guangzhou Xinbo Electronic Co., Ltd. · Aug 2023
Conductive Silicone Rubber Electrode
K231167 · Guangzhou Xinbo Electronic Co., Ltd. · Aug 2023
Ceribell Instant EEG Headband
K232052 · Ceribell, Inc. · Aug 2023
Ceribell Instant EEG Headcap
K223086 · Ceribell, Inc. · Mar 2023
Motive™ Electrode
K230533 · Cymedica Orthopedics, Inc. · Mar 2023
DeltaScan Patch
K222671 · Prolira B.V. · Feb 2023