Cleared Traditional

Medical Endoscope Image Processing System (K210270) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 93
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