# K243527: High Flow Insufflation Unit (UHI-4)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jan 13, 2025 after 60 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K964171 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122180: High Flow Insufflantion Unit, Olympus Medical Systems Corporation (2012) Summary page 5.

## Recalls of this device
- Jun 16, 2026 · Class II · Z-2776-2026: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

## Indications for use
The UHI-4 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/K243527
Methodology: https://510kreport.com/methodology