# K181418: ScopeFlow Pure (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Partnership Medical Limited
- Decided: Jul 11, 2019 after 406 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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: 3 generations back to K790071 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140753: Endo Smart Bottle, Rinse and Insufflation System, Medivators (2014) Summary page 8.
- K971125: Endo Smartcap (100501), Endo Smart Cap Co. (1997) Summary page 8.

## Indications for use
The ScopeFlow Pure™ is designed to be used in conjunction with a flexible endoscope to insufflate air/CO2 and supply sterile water during endoscopic procedures. The ScopeFlow Pure™ is compatible with the different sterile water bottles available. It is intended to be used for 24 hours and then disposed of.

Source page: https://510kreport.com/device/K181418
Methodology: https://510kreport.com/methodology