# K014166: Uhi-3 High Flow Insufflation Unit

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Jun 25, 2002 after 188 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: 1 generation back to K983326 (1999). 1 ancestor in all.
33 later devices descend from it; 1 cites it directly.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983326: Omniflator 7640 Model 7-640-00, Northgate Technologies, Inc. (1999) Summary page 2.

## Cited in the summary but kept off the family tree
- K095316: OLYMPUS High Flow Insufflation Unit (UHI). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K110294: High Flow Insufflation Unit Uhi-4 (2011), 32 descendants of its own
- 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

## Recalls of this device
- Jan 16, 2026 · Class I · Z-1354-2026: Issue with software algorithm which may lead to overpressure events.

## Indications for use
This instrument has been designed for insufflation of the abdominal cavity, and automatic suction and smoke evacuation. This instrument uses C 0 2gas for distension, and it may be used for diagnostic andlor operative laparoscopy,

Source page: https://510kreport.com/device/K014166
Methodology: https://510kreport.com/methodology