# K110766: Kolplux System

- Pathway: 510(k) (Traditional)
- Applicant: Kolplast CI Ltda
- Decided: Sep 15, 2011 after 181 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 K941272 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070964: Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System, Welch Allyn, Inc. (2007) Summary page 1.

## Indications for use
The KOLPLUX System when used with a vaginal speculum provides illumination during pelvic examination and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.

Source page: https://510kreport.com/device/K110766
Methodology: https://510kreport.com/methodology