510(k) · Cleared
ClearedSingle-use Video Scope; PB Digital Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirco-Tech (Nanjing) Co., Ltd. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Apr 3, 2026 as substantially equivalent to K221784 (Micro-Tech (Nanjing) Co., Ltd., 2023) and 1 other predicate after a 102-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 3, 2026
- Review
- 102 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 2
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 deviceK254153 Single-use Video Scope; PB Digital ControllerMirco-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 deviceK254153 Single-use Video Scope; PB Digital ControllerMirco-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) | K254153 | Single-use Video Scope; PB Digital Controller | Mirco-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.
Top candidate predicates for a new FBN device
- #1 K221784 Single-use Video Pancreaticobiliary Scope, PB…score 13.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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…00 Product Code(s) FBN, FET I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221784 Single-use Video Pancreaticobiliary Scope, PB Digital Controller | | FBN K142922 SpyGlass DS Access and Delivery Catheter FBN De… | 2023 |
| * | K142922 | SpyGlass DS Direct Visualization SystemSummary page 5…a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221784 Single-use Video Pancreaticobiliary Scope, PB Digital Controller | | FBN K142922 SpyGlass DS Access and Delivery Catheter FBN Device Description Summary 21 CFR 807.92(a)(4) The Pancreaticobiliary Video System… | 2015 |
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 · 5 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 8 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 FBN devicesFBN Choledochoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FBN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBN
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBN
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FBN
118in 2025
MAUDE reports naming product code FBN, 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 | 1 |
| 2008 | 3 | 64 | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 168 |
| 2017 | 0 | — | 0 | 224 |
| 2018 | 1 | — | 0 | 639 |
| 2019 | 1 | — | 0 | 105 |
| 2020 | 1 | — | 1 | 173 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 0 | — | 0 | 283 |
| 2023 | 4 | 215 | 1 | 105 |
| 2024 | 2 | — | 1 (1) | 107 |
| 2025 | 3 | 150 | 0 | 118 |
| 2026 | 3 | 175 | 1 | — |
What is it indicated for?
Single-use Video Scope:The Single-use Video Scope is used in combination with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254153: Single-use Video Scope; PB Digital Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254153
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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