Cleared Traditional

K253771 - Disposable Microwave Ablation Antenna (...

K253771 is an FDA 510(k) clearance for Disposable Microwave Ablation Antenna (..., manufactured by Nanjing Devin Medical Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K253771 · Nanjing Devin Medical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
96d
Days
Class 2
Risk

K253771 is an FDA 510(k) clearance for the Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR.... Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Nanjing Devin Medical Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on March 2, 2026 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanjing Devin Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K253771

510(k) Number K253771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2025
Decision Date March 02, 2026
Days to Decision 96 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEY Device Classification - Class 2, Special Controls

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

APlus Healthcare Technology (Shanghai) Co., Ltd.
Jack Fang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 39
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K253771.
Microwave Ablation Device
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K250718 · Emblation Limited · Aug 2025
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K241827 · Canyon Medical, Inc. · Sep 2024
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