# K201361: Pneumoclear

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Jul 29, 2020 after 68 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). 34 ancestors in all.
14 later devices descend from it; 3 cite it directly.
3 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170784: Pneumoclear, W.O.M. World of Medicine GmbH (2017) Summary page 4.

## Most influential descendants
- 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
- K251202: da Vinci Surgical System (IS5000) (2025), 1 descendant of its own

## 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 CO₂ 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 transanal minimally invasive surgery.

Source page: https://510kreport.com/device/K201361
Methodology: https://510kreport.com/methodology