# K152278: ENDOFLOW II - Irrigation, Warming and Suction System

- Pathway: 510(k) (Traditional)
- Applicant: Promepla Sam
- Decided: Feb 9, 2016 after 181 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: 4 generations back to K933002 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600,, Smiths Medical Asd, Inc. (2008) Summary page 6.
- K113119: Endogator Advantage Irrigation Pump, Byrne Medical, Inc. (2012) Summary page 6.
- K954465: FMS Duo, Future Medical Systems, Inc. (1995) Summary page 6.

## Indications for use
The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

Source page: https://510kreport.com/device/K152278
Methodology: https://510kreport.com/methodology