# K132668: Iob Disposable Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Iob Medical, Inc.
- Decided: Jan 17, 2014 after 143 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 K091937 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091937: Office-Spec Disposable Side-Opening Speculum, Obp Corporation (2009) Summary page 1.

## Indications for use
The 108 Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.

Source page: https://510kreport.com/device/K132668
Methodology: https://510kreport.com/methodology