# K092870: Non-Sterile Disposable Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Kunshan Deyi Plastic Co., Ltd.
- Decided: Feb 16, 2010 after 151 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
Longest line of descent: 1 generation back to K050887 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050887: Gongdong Disposable Vaginal Speculum, Zhejiang Gongdong Medical Plastic Factory (2005) Summary page 1.

## Indications for use
The disposable vaginal speculum is a non-sterile product and is intended to be used by a medical professional to Visualize the interior of the vagina and cervix during obstetrical and gynecological examination.

Source page: https://510kreport.com/device/K092870
Methodology: https://510kreport.com/methodology