# K213833: SCOPE BUDDY PLUS Endoscope Flushing Aid

- Pathway: 510(k) (Special)
- Applicant: Medivators, Inc.
- Decided: Jan 14, 2022 after 36 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K914524 (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)
- K162128: Scope Buddy Plus Endoscope Flushing Aid, Medivators, Inc. (2016) Summary page 5.

## Indications for use
SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.

Source page: https://510kreport.com/device/K213833
Methodology: https://510kreport.com/methodology