# K122180: High Flow Insufflantion Unit

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Nov 13, 2012 after 113 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K964171 (1997). 19 ancestors in all.
31 later devices descend from it; 3 cite it directly.
3 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110294: High Flow Insufflation Unit Uhi-4, Olympus Medical Systems Corporation (2011) Summary page 2.
- K000180: Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal Endoscop, Richard Wolf Medical Instruments Corp. (2001) Summary page 2.

## Most influential descendants
- 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
- K172516: SurgiQuest AIRSEAL iFS System (2018), 8 descendants of its own

## Recalls of this device
- 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 is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment. This instrument is intended 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. This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.

Source page: https://510kreport.com/device/K122180
Methodology: https://510kreport.com/methodology