# K110294: High Flow Insufflation Unit Uhi-4

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Nov 18, 2011 after 290 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K964171 (1997). 17 ancestors in all.
32 later devices descend from it; 1 cites it directly.
3 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063367: 45L Core Insufflator, Model F114, W.O.M. World of Medicine AG (2007) Summary page 2.
- K014166: Uhi-3 High Flow Insufflation Unit, Olympus Optical Co., Ltd. (2002) Summary page 2.

## Most influential descendants
- K122180: High Flow Insufflantion Unit (2012), 31 descendants of its own
- K143404: SurgiQuest AirSeal iFS System (2015), 27 descendants of its own
- K170784: Pneumoclear (2017), 17 descendants of its own
- K201361: Pneumoclear (2020), 14 descendants of its own
- K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (2024), 11 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-1375-2024: Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
- Sep 22, 2023 · Class I · Z-0075-2024: There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation 

## Indications for use
This instrument has been designed for insufflation of abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment. This instrument is also designed for controlled CO2 insufflation to create a cavity along the saphenous vein and/or radial artery to facilitate observation during an endoscopic vessel harvesting procedure.

Source page: https://510kreport.com/device/K110294
Methodology: https://510kreport.com/methodology