# K250388: Endoflator +

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Sep 22, 2025 after 223 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). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201361: Pneumoclear, W.O.M. World of Medicine GmbH (2020) Summary page 5.

## Most influential descendants
- K260209: ENDOFLATOR+; Smart Smoke Evacuation (2026), 0 descendants of its own

## 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 and Pediatric modes are 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 laparoscopic procedure in pediatrics aged 2 and up. * 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.

Source page: https://510kreport.com/device/K250388
Methodology: https://510kreport.com/methodology