# K072762: Depalt Vaginal Specuim and Depalt Lighting System

- Pathway: 510(k) (Traditional)
- Applicant: Depalt, Inc.
- Decided: Jan 22, 2008 after 116 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: 2 generations back to K020726 (2002). 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)
- K070964: Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System, Welch Allyn, Inc. (2007) Summary page 1.
- K052314: Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large, Dynarex Corp. (2005) Summary page 1.
- (no number) Bionix Reddy Lite: named in the summary without a submission number

## Most influential descendants
- K133857: Brella-Spec (TM) Vaginal Speculum (2014), 0 descendants of its own

## Indications for use
Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations. Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.

Source page: https://510kreport.com/device/K072762
Methodology: https://510kreport.com/methodology