# K191780: AP50/30 Insufflator with Insuflow Port

- Pathway: 510(k) (Traditional)
- Applicant: Lexion Medical, LLC
- Decided: Aug 28, 2019 after 57 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: 10 generations back to K964171 (1997). 48 ancestors in all.
No later device cites it as a predicate yet.
3 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170799: AP 50/30 Insufflator with Insuflow Port, Lexion Medical, LLC (2017) Summary page 4.
- K170784: Pneumoclear, W.O.M. World of Medicine GmbH (2017) Summary page 4.

## 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 TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery. 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/K191780
Methodology: https://510kreport.com/methodology