Cleared Traditional

K252793 - ARMI Endoscopic Video Image Processor (...

Also marketed or referenced as:
ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

K252793 is an FDA 510(k) clearance for ARMI Endoscopic Video Image Processor (..., manufactured by Jiangsu Jiyuan Medical Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K252793 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
111d
Days
Class 2
Risk

K252793 is an FDA 510(k) clearance for the ARMI® Endoscopic Video Image Processor (JY-MIP-3000). Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Jiangsu Jiyuan Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on December 18, 2025 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K252793

510(k) Number K252793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2025
Decision Date December 18, 2025
Days to Decision 111 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 160d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 109
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K252793.
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K252012 · Stryker Endoscopy · Jul 2025
RZ Resectoscope System
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K240978 · MacroLux Medical Technology Co., Ltd. · Aug 2024