510(k) · Cleared
ClearedBlue Eye
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 Jul 3, 2024 as substantially equivalent to K220434 (The Standard Co., Ltd., 2022) after a 30-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jul 3, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- PLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K935844 (1995). 11 ancestors in all, the oldest K934356 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 7 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 6 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 5 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 4 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 3 generations backK111495 Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc. · 2011
- 2 generations backK150852 SIC 8000Cosmo Technologies, Ltd. · 2015
- 1 generation backK220434 Blue Eye (TS-905)The Standard Co., Ltd. · 2022
- This deviceK241591 Blue EyeThe Standard Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −7 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −6 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −5 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −4 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −3 | K111495 | Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K | Wilson-Cook Medical, Inc. | 2011 | — |
| −2 | K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015 | — |
| −1 | K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K220434 | Blue Eye (TS-905)Summary page 5…on name: Submucosal injection agent • Classification name: Endoscope and Accessories (21CFR 876.1500, Product code: PLL) 3. Predicate Device: • Blue Eye (K220434) manufactured by The Standard Co., Ltd. Blue Eye (TS-910) [subject device] is substantially equivalent in term of its in terms… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All PLL devicesPLL Submucosal Injection Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 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/K241591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241591: Blue Eye.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241591
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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