# K881004: Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr

- Pathway: 510(k) (Traditional)
- Applicant: Keymed, Inc.
- Decided: May 12, 1988 after 64 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063786: Endoscopic Insufflation Unit, Model Xecr-2 (2007), 2 descendants of its own
- K133976: Fujifilm Endoscopic CO2 Regulator (2014), 1 descendant of its own
- K180711: FUJIFILM Endoscopic CO2 Regulator GW-100 (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K881004
Methodology: https://510kreport.com/methodology