# K052912: Yusheng Disposable Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Yusheng Medical Instrument Co., Ltd.
- Decided: Dec 15, 2005 after 59 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The YuSheng Disposable Vaginal Speculum is non sterile products and is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during the obstetrical and gynecological procedures.

Source page: https://510kreport.com/device/K052912
Methodology: https://510kreport.com/methodology