# K063367: 45L Core Insufflator, Model F114

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: May 23, 2007 after 197 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964171 (1997). 14 ancestors in all.
44 later devices descend from it; 7 cite it directly.
2 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060723: 40 L High Flow Insufflator F113, W.O.M. World of Medicine AG (2006) Summary page 1.
- K031014: HI-Flo Therme Pneu 45, Wisap #7083, 7083V, Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (2003) Summary page 1.
- K003792: Stryker Heated Insufflator Tube Set, Stryker Corp. (2001) Summary page 1.
- K950035: Surgiflator 20, W.O.M. GmbH (1996) Summary page 1.

## Most influential descendants
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- 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
- K120151: Nebulae I (2012), 22 descendants of its own

## Recalls of this device
- Mar 7, 2019 · Class II · Z-1726-2019: The heated tube sets were consistently leaking and detaching from the cassette.
- Mar 7, 2019 · Class II · Z-1727-2019: The heated tube sets were consistently leaking and detaching from the cassette.
- Mar 28, 2016 · Class II · Z-1566-2016: When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Suppl
- Dec 29, 2008 · Not classified · Z-1198-2010: Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up

## Indications for use
The 45L CORE Insufflator F114 is a C02 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application, the low flow application and the bariatric application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F114 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

Source page: https://510kreport.com/device/K063367
Methodology: https://510kreport.com/methodology