# K260209: ENDOFLATOR+; Smart Smoke Evacuation

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Aug 19, 2026 after 208 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: 12 generations back to K931783 (1993). 54 ancestors in all.
No later device cites it as a predicate yet.
3 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250388: Endoflator +, Karl Storz SE & CO. KG (2025) Summary page 5.
- K201361: Pneumoclear, W.O.M. World of Medicine GmbH (2020) Summary page 5.
- K201434: Connected OR Hub with Voice Control, Connected OR Hub with Device Control, Stryker (2020) Summary page 5.

## Indications for use
The ENDOFLATOR + is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas with the following operating modes: High Flow mode is indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. Pediatric mode is indicated to fill and distend a peritoneal cavity with gas during a pediatric laparoscopic procedure. EVH mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. taTME mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery. The smart smoke evacuation software is an optional feature that triggers smoke evacuation of the compatible insufflator through analysis of the smoke volume in the endoscopic image.

Source page: https://510kreport.com/device/K260209
Methodology: https://510kreport.com/methodology