# K050887: Gongdong Disposable Vaginal Speculum

- Pathway: 510(k) (Abbreviated)
- Applicant: Zhejiang Gongdong Medical Plastic Factory
- Decided: Jul 11, 2005 after 95 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K130046: Clearspec Single Use Vaginal Speculum (2013), 1 descendant of its own
- K252208: JFord Speculum Sleeve™ (2026), 0 descendants of its own
- K092870: Non-Sterile Disposable Vaginal Speculum (2010), 0 descendants of its own

## Indications for use
The Gongdong 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/K050887
Methodology: https://510kreport.com/methodology