# K042950: Vag O Speculum, Models VS1, VM1, VL1

- Pathway: 510(k) (Traditional)
- Applicant: Panatrex, Inc.
- Decided: Nov 30, 2004 after 35 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kleenspec (Welch Allyn Vaginal Speculum): named in the summary without a submission number

## Most influential descendants
- K052420: G-Spec Articulated Weighted Vaginal Speculum (2006), 0 descendants of its own

## Indications for use
To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.

Source page: https://510kreport.com/device/K042950
Methodology: https://510kreport.com/methodology