Cleared Traditional

K253747 - Disposable Pen Injector (KXYC-03C02, KXYC-03A03)

K253747 is an FDA 510(k) clearance for Disposable Pen Injector (KXYC-03C02, manufactured by Jiangsu Enjosim Medical Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K253747 · Jiangsu Enjosim Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
262d
Days
Class 2
Risk

K253747 is an FDA 510(k) clearance for the Disposable Pen Injector (KXYC-03C02, KXYC-03A03). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangsu Enjosim Medical Technology Co., Ltd. (Wu Xi, CN). The FDA issued a Cleared decision on August 14, 2026 after a review of 262 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Jiangsu Enjosim Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K253747

510(k) Number K253747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2025
Decision Date August 14, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 129d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Hospital devices follow this clearance model.

Regulatory Consultant

Elite Medical Technology Co., Ltd.
Ryan Li

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.

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All 480
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