# K161554: Endoflator 40, Endoflator 50

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Mar 2, 2017 after 269 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: 7 generations back to K964171 (1997). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 25 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.
- K122180: High Flow Insufflantion Unit, Olympus Medical Systems Corporation (2012) Summary page 4.

## Most influential descendants
- K221995: Gas Insufflator (2023), 0 descendants of its own

## Indications for use
The ENDOFLATOR 40 & 50 are used to create and/or to distend a cavity in the following diagnostic and therapeutic interventions: * Laparoscopy * Pediatric Laparoscopy * Endoscopy of the Lower Gastrointestinal Tract (e.g., TEO, colonoscopy) * Endoscopic Vessel Harvesting

Source page: https://510kreport.com/device/K161554
Methodology: https://510kreport.com/methodology