# K170784: Pneumoclear

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: May 15, 2017 after 61 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K964171 (1997). 33 ancestors in all.
17 later devices descend from it; 3 cite it directly.
3 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153513: Insufflator 50L FM134, W.O.M. World of Medicine GmbH (2016) Summary page 4.
- K143404: SurgiQuest AirSeal iFS System, Surgiquest, Inc. (2015) Summary page 5.

## Most influential descendants
- 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
- K250388: Endoflator + (2025), 1 descendant of its own

## Recalls of this device
- Oct 22, 2018 · Class II · Z-0508-2019: It is possible that the packaging of the product can be damaged by the prongs on the tube set.

## Indications for use
The device PNEUMOCLEAR™ 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/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest 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.

Source page: https://510kreport.com/device/K170784
Methodology: https://510kreport.com/methodology