510(k) · Cleared
ClearedBlue Eye (TS-905)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Standard Co., Ltd. · PLL Submucosal Injection Agent
Cleared on Aug 12, 2022 as substantially equivalent to K150852 (Cosmo Technologies, Ltd., 2015) after a 178-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Aug 12, 2022
- Review
- 178 days
- Class
- Class II
- Product code
- PLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935844 (1995). 10 ancestors in all, the oldest K934356 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 6 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 5 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 4 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 3 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 2 generations backK111495 Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc. · 2011
- 1 generation backK150852 SIC 8000Cosmo Technologies, Ltd. · 2015
- This deviceK220434 Blue Eye (TS-905)The Standard Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK241591 Blue EyeThe Standard Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241591Blue EyeThe Standard Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −6 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −5 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −4 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −3 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −2 | K111495 | Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K | Wilson-Cook Medical, Inc. | 2011 | — |
| −1 | K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015 | — |
| 0 (this device) | K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | 2022 | — |
| +1 | K241591 | Blue Eye | The Standard Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLL device
- #1 K260997 Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150852 | SIC 8000Summary page 4…injection agent Classification name: Submucosal injection agent, 21CFR 876.1500 Product code: PLL 3. Predicate Device: SIC 8000, K150852(Product Code: PLL, 21CFR 876.1500) by Cosmo Technologies Ltd. 4. Description: The Blue Eye (TS-905), submucosal injection… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241591 | Blue Eye | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K241591 (The Standard Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K150852.
How does its category compare?
All PLL devicesPLL Submucosal Injection Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PLL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLL
280in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLL
3in 2024
MAUDE reports naming product code PLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 4 | 280 | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 1 | 36 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220434: Blue Eye (TS-905).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220434
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026