# K170799: AP 50/30 Insufflator with Insuflow Port

- Pathway: 510(k) (Traditional)
- Applicant: Lexion Medical, LLC
- Decided: Nov 14, 2017 after 242 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: 9 generations back to K964171 (1997). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 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.
- K153513: Insufflator 50L FM134, W.O.M. World of Medicine GmbH (2016) Summary page 4.
- K140263: Insuflow Synergy Port, Insuflow Synergy XL Port, Lexion Medical, LLC (2014) Summary page 4.

## Most influential descendants
- K191780: AP50/30 Insufflator with Insuflow Port (2019), 0 descendants of its own

## Indications for use
The AP50/30 Insufflator 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/High Flow, 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. The Insuflow® Port (5 mm, 8 mm, 10mm and 12mm) devices have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

Source page: https://510kreport.com/device/K170799
Methodology: https://510kreport.com/methodology