# K130046: Clearspec Single Use Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Clearspec, LLC
- Decided: Aug 6, 2013 after 210 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: 3 generations back to K941272 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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.
- K120743: Speculum, Vaginal, Nonmetal, Welch Allyn, Inc. (2012) Summary page 1.

## Most influential descendants
- K252208: JFord Speculum Sleeve™ (2026), 0 descendants of its own

## Indications for use
The ClearSpec® Single-Use Vaginal Speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.

Source page: https://510kreport.com/device/K130046
Methodology: https://510kreport.com/methodology