510(k) · Cleared
ClearedBlue Beacon Submucosal Injectable Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · PLL Submucosal Injection Agent
Cleared on Nov 3, 2020 as substantially equivalent to K150852 (Cosmo Technologies, Ltd., 2015) after a 295-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Nov 3, 2020
- Review
- 295 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). No later device cites it as a predicate yet.
- 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 deviceK200071 Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd. · 2020
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) | K200071 | Blue Beacon Submucosal Injectable Solution | Micro-Tech (Nanjing) Co., Ltd. | 2020 | — |
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.
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 25 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.
- 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. 2020, 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?
Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state 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/K200071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200071: Blue Beacon Submucosal Injectable Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200071
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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