# K201096: CO2mbiLED

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Jun 23, 2020 after 60 days
- Product code: FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923982 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator, Bracco Diagnostic, Inc. (2011) Summary page 4.
- K082925: Xenon-100 SCB Light Source, Model 20132620, KARL STORZ Endoscopy-America, Inc. (2008) Summary page 4.

## Indications for use
The CO2mbi LED SCB is a combination of an LED light source, intended to provide illumination, and an insufflation/irrigation pump, intended to insufflate CO2 or air as a distention media in the gastrointestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.

Source page: https://510kreport.com/device/K201096
Methodology: https://510kreport.com/methodology