# K252793: ARMI® Endoscopic Video Image Processor (JY-MIP-3000); 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)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Jiyuan Medical Technology Co., Ltd.
- Decided: Dec 18, 2025 after 111 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931154 (1993). 37 ancestors in all.
No later device cites it as a predicate yet.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210270: Medical Endoscope Image Processing System, Jiangsu Jiyuan Medical Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
ARMI® Hysteroscopy System 2.0 is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

Source page: https://510kreport.com/device/K252793
Methodology: https://510kreport.com/methodology