# K101094: Clearjet

- Pathway: 510(k) (Traditional)
- Applicant: Easyglide, Ltd.
- Decided: May 17, 2010 after 27 days
- Product code: ODC (Endoscope Channel Accessory)
- 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: 6 generations back to K921244 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091305: Clearpath, Easyglide, Ltd. (2009) Summary page 1.
- K070420: Bioshield-Ercp Biopsy Valve, Model 00711138, United States Endoscopy Group, Inc. (2007) Summary page 2.

## Indications for use
The ClearJet is an irrigation /biopsy adapter set used to cover the opening to the biopsy/ suction / irrigation channel of Pentax, Olympus and Fuijinon endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access, for irrigation. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

Source page: https://510kreport.com/device/K101094
Methodology: https://510kreport.com/methodology