# K050112: Pro Fit Disposable Rectal Speculum, Models 8116 and 8117

- Pathway: 510(k) (Traditional)
- Applicant: Prime Pacific Health Innovations Corporation
- Decided: Mar 15, 2005 after 56 days
- Product code: KPL (Colonic Irrigation System)
- Device class: 2
- Regulation: 21 CFR 876.5220
- 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 K000388 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000388: Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small), Clearwater Colon Hydrotherapy, Inc. (2000) Summary page 1.
- (no number) Clearwater Colon Hydrotherapy, Inc. Disposable Speculum: named in the summary without a submission number
- (no number) Specialty Health Products Inc. Disposable Speculum: named in the summary without a submission number
- (no number) Dotolo Research Corp. Disposable Speculum: named in the summary without a submission number

## Most influential descendants
- K152834: Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 (2016), 0 descendants of its own

## Indications for use
The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination. The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Source page: https://510kreport.com/device/K050112
Methodology: https://510kreport.com/methodology