# K153513: Insufflator 50L FM134

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Mar 4, 2016 after 88 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K964171 (1997). 17 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 39 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 4.
- K120151: Nebulae I, Northgate Technologies, Inc. (2012) Summary page 5.

## Most influential descendants
- 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
- K251739: da Vinci Surgical System (IS5000) (2026), 2 descendants of its own
- K241284: da Vinci Surgical System (IS5000) (2024), 2 descendants of its own

## Indications for use
The device Insufflator 50L FM134 is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

Source page: https://510kreport.com/device/K153513
Methodology: https://510kreport.com/methodology