510(k) · Cleared
ClearedVisualized Access and Delivery Catheter; PB Digital Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · SHU Appendiceal Scope And Accessories, Flexible
Cleared on Apr 24, 2026 as substantially equivalent to K221784 (Micro-Tech (Nanjing) Co., Ltd., 2023) after a 259-day review. Its family tree reaches back 12 generations to 1993. 2 of the 50 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 24, 2026
- Review
- 259 days
- Class
- Class II
- Product code
- SHU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K931154 (1993). 49 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 2 of the 50 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations between
- 3 generations backK142556 Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014
- 2 generations backK200483 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital…Boston Scientific Corporation · 2020
- 1 generation backK221784 Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2023
- This deviceK252492 Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 10 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 9 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 8 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 7 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 6 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 5 generations backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 4 generations backK141250 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014 · Recalled
- 3 generations backK142556 Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014
- 2 generations backK200483 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital…Boston Scientific Corporation · 2020
- 1 generation backK221784 Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2023
- This deviceK252492 Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −11 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −10 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −9 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −8 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −7 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −6 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −5 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| −4 | K141250 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2014 | 2 |
| −3 | K142556 | Flexible Video-Uretero-Choledochoscope System | KARL STORZ Endoscopy-America, Inc. | 2014 | — |
| −2 | K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | 2020 | — |
| −1 | K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | 2023 | — |
| 0 (this device) | K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 4 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2003 | 3 | 1 |
| 2005 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital ControllerSummary page 5…plicant Contact: Ms. Sally He Applicant Contact Telephone: +86-25-58646378 Applicant Contact Email: [email protected] Legally Marketed Predicate Devices 510(k) Number: K221784 Predicate Trade Name: Single-use Video Pancreaticobiliary Scope, PB Digital Controller Product Code: FBN Device Name Device Tr… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 18 of the 49 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K221784.
How does its category compare?
All SHU devicesSHU Appendiceal Scope And Accessories, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHU
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHU
Too few SHU 510(k)s in any year since 2007 to give a median.
Recalls per year · SHU
No recall names SHU since 2007.
Adverse event reports per year · SHU
No MAUDE report names SHU since 2007.
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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Visualized Access and Delivery Catheter: The Visualized Access and Delivery Catheter have beien designed to be used with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of vermiform appendix, and provide working channel for other diagnosis and treatment accessories. The Visualized Access and Delivery Catheter is to be used with a colonoscope for appendicitis…
Read the full statement (106 words)
Visualized Access and Delivery Catheter:
The Visualized Access and Delivery Catheter have beien designed to be used with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of vermiform appendix, and provide working channel for other diagnosis and treatment accessories.
The Visualized Access and Delivery Catheter is to be used with a colonoscope for appendicitis diagnosis and treatment procedures under direct visualization in adults, adolescents, and children.
PB Digital Controller:
The PB Digital Controller can be used together with the endoscope to process the image collected by the endoscope and transmit it to the display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252492 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252492: Visualized Access and Delivery Catheter; PB Digital Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252492
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026