Cleared Traditional

K210270 - Medical Endoscope Image Processing System

K210270 is an FDA 510(k) clearance for Medical Endoscope Image Processing System, 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 242-day FDA review.

K210270 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Obstetrics & Gynecology device
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Oct 2021
Decision
242d
Days
Class 2
Risk

K210270 is an FDA 510(k) clearance for the Medical Endoscope Image Processing System. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Jiangsu Jiyuan Medical Technology Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on October 1, 2021 after a review of 242 days - an extended review cycle.

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 - K210270

510(k) Number K210270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date October 01, 2021
Days to Decision 242 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
82d slower than avg
Panel avg: 160d · This submission: 242d
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 Consultant

Microkn Business Consulting (Shanghai) Co., Ltd.
Yuling Chen

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 - HIH Hysteroscope (and Accessories)

All 109
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K210270.
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
K213171 · Meditrina, Inc. · May 2022
Sheath, Stopcock Accessory
K213207 · Olympus Winter & Ibe GmbH · Dec 2021
Hystero-V Hysteroscope
K202445 · Hysterovue, Inc. · Nov 2021
HTx Disposable Hysteroscope System
K211227 · Acuvu, Inc. · Sep 2021
BenestaTM Tissue Removal Device
K192811 · Caldera Medical, Inc. · Oct 2020
Schoelly Cystoscopes/Hysteroscopes and Accessories
K201970 · Schoelly Fiberoptic GmbH · Oct 2020