# K052192: Femspce-S Disposable Sterile Vaginal Speculum, Model ST-I

- Pathway: 510(k) (Traditional)
- Applicant: Femspec LLC
- Decided: Feb 2, 2006 after 175 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The FernSpec, LLC, FemSpec-Sterile TM Disposable Sterile Vaginal Speculum is indicated for diagnostic procedures of the cervix.

Source page: https://510kreport.com/device/K052192
Methodology: https://510kreport.com/methodology