# K133857: Brella-Spec (TM) Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Proa Medical, Inc.
- Decided: Apr 28, 2014 after 130 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 K020726 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072762: Depalt Vaginal Specuim and Depalt Lighting System, Depalt, Inc. (2008) Summary page 2.

## Indications for use
The Brella-Spec Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. Brella-Spec Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.

Source page: https://510kreport.com/device/K133857
Methodology: https://510kreport.com/methodology