# K041757: Femspec Disposable Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Femspec LLC
- Decided: Dec 23, 2004 after 177 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 K984211 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012535: DRG Disposable Vaginal Speculum, Doctor'S Research Group, Inc. (2002) Summary page 1.

## Indications for use
The FemSpec TM disposable vaginal speculum is indicated for diagnostic procedures of the cervix.

Source page: https://510kreport.com/device/K041757
Methodology: https://510kreport.com/methodology