# K091937: Office-Spec Disposable Side-Opening Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Obp Corporation
- Decided: Sep 9, 2009 after 71 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132668: Iob Disposable Speculum (2014), 0 descendants of its own

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2933-2026: There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

## Indications for use
The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.

Source page: https://510kreport.com/device/K091937
Methodology: https://510kreport.com/methodology