# K220434: Blue Eye (TS-905)

- Pathway: 510(k) (Traditional)
- Applicant: The Standard Co., Ltd.
- Decided: Aug 12, 2022 after 178 days
- Product code: PLL (Submucosal Injection Agent)
- 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: 7 generations back to K935844 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150852: SIC 8000, Cosmo Technologies, Ltd. (2015) Summary page 4.

## Most influential descendants
- K241591: Blue Eye (2024), 0 descendants of its own

## Indications for use
The Blue Eye (TS-905) is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device.

Source page: https://510kreport.com/device/K220434
Methodology: https://510kreport.com/methodology