Cleared Traditional

K252853 - CAD - Lower GI (EC07-01)

K252853 is an FDA 510(k) clearance for CAD - Lower GI (EC07-01), manufactured by Xiamen Inno Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code QNP cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K252853 · Xiamen Inno Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
331d
Days
Class 2
Risk

K252853 is an FDA 510(k) clearance for the CAD - Lower GI (EC07-01). Classified as Gastrointesinal Lesion Software Detection System (product code QNP), Class II - Special Controls.

Submitted by Xiamen Inno Medical Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on August 5, 2026 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1520 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Xiamen Inno Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K252853

510(k) Number K252853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2025
Decision Date August 05, 2026
Days to Decision 331 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 131d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QNP Device Classification - Class 2, Special Controls

Product Code QNP Gastrointesinal Lesion Software Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1520
Definition A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Zhihe Info-Tech(Suzhou) Co., Ltd.
Rachel Yu

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 - QNP Gastrointesinal Lesion Software Detection System

All 21
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