# K070964: Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: May 18, 2007 after 43 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 K941272 (1994). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941272: Kleenspec, Welch Allyn, Inc. (1994) Summary page 1.

## Most influential descendants
- K120743: Speculum, Vaginal, Nonmetal (2012), 2 descendants of its own
- K130046: Clearspec Single Use Vaginal Speculum (2013), 1 descendant of its own
- K072762: Depalt Vaginal Specuim and Depalt Lighting System (2008), 1 descendant of its own
- K252208: JFord Speculum Sleeve™ (2026), 0 descendants of its own
- K133857: Brella-Spec (TM) Vaginal Speculum (2014), 0 descendants of its own

## Indications for use
KleenSpec® Single Use Vaginal Speculum 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. KleenSpec® 790 Series Cordless 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/K070964
Methodology: https://510kreport.com/methodology