# K052314: Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corp.
- Decided: Nov 9, 2005 after 76 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 K020726 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K020726: Dukal Disposable Vaginal Speculum, Small, Medium, and Large, Dukal Corp. (2002) Summary page 1.

## Most influential descendants
- K072762: Depalt Vaginal Specuim and Depalt Lighting System (2008), 1 descendant of its own
- K133857: Brella-Spec (TM) Vaginal Speculum (2014), 0 descendants of its own

## Indications for use
This device is used to expose the interior of the vagina.

Source page: https://510kreport.com/device/K052314
Methodology: https://510kreport.com/methodology