# K120743: Speculum, Vaginal, Nonmetal

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Mar 23, 2012 after 11 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941272 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070964: Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System, Welch Allyn, Inc. (2007) Summary page 1.

## 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

## Recalls of this device
- Oct 2, 2015 · Class II · Z-0169-2016: The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer p

## Indications for use
The disposable 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. The vaginal speculum can be used with or without the illuminator. When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery. The illuminator can be used independent of the speculum as a general-purpose light source.

Source page: https://510kreport.com/device/K120743
Methodology: https://510kreport.com/methodology