510(k) · Cleared
Recalled · Class II · 2017SpyGlass DS Direct Visualization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Jan 16, 2015 as substantially equivalent to K060269 (Acmi Corporation, 2006) and 4 other predicates after a 100-day review. Its family tree reaches back 7 generations to 1993. 2 of the 50 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2015
- Review
- 100 days
- Class
- Class II
- Product code
- FBN
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K931154 (1993). 40 ancestors in all, the oldest K843084 (1985). 9 later devices descend from it, 4 citing it directly. 2 of the 50 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 3 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 2 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 1 generation backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- This deviceK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015
- Descendant · cites it directly · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
- Descendant · 2 generations on · 5 of its ownK183636 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and…Boston Scientific Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK200483 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital…Boston Scientific Corporation · 2020
- Descendant · cites it directly · 2 of its ownK221784 Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252492 Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · cites it directly7descendants
- K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation · 2019 · 2 generations on5descendants
- K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation · 2020 · 3 generations on3descendants
- K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2023 · cites it directly2descendants
- K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −3 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −1 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| 0 (this device) | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | — |
| +1 | K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018 | — |
| +2 | K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery… | Boston Scientific Corporation | 2019 | — |
| +3 | 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 | — |
| +2 | 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 | 4 | 0 |
| 2003 | 3 | 1 |
| 2005 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 K254153 Single-use Video Scope; PB Digital Controllerscore 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemSummary page 4…and Choledochoscope System Manufacturer: ACMI Corporation Clearance Number: K060269 Common Name: Choledochoscope and accessories, flexible/rigid Product Code:… | 2006 |
| * | K090170 | Spyscope Access and Delivery CatheterSummary page 4…SpyScope Access and Delivery Catheter Manufacturer: Boston Scientific Corporation Clearance Number: K090170 SpyGlass DS Direct Visualization System Premarket Notification Volume 001 Page 43 of 458 B… | 2009 |
| * | K052194 | Spyglass Direct Visualization Probe and OcularSummary page 5…SpyGlass Direct Visualization Probe/Ocular Manufacturer: Boston Scientific Corporation Clearance Number: K052194 Common Name: Endoscope and/or accessories Product Code: KOG Device Class… | 2005 |
| * | K080586 | Olympus XCHF Type B180Y1Summary page 5…Olympus XCHF-B180Y1 Choledochoscope Manufacturer: Olympus Medical Systems Corporation Clearance Number: K080586 Common Name: Choledochoscope and accessories, flexible/rigid Product Code:… | 2008 |
| * | K082813 | Stryker Led LightsourceSummary page 5…Trade Name: Stryker LED Light Source Manufacturer: Stryker Endoscopy Clearance Number: K082813 Common Name: Light source, fiberoptic, routine Product Code: FCW Device… | 2008 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2017 | Class II | Z-1133-2018 | Process design | Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding. |
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 15 of the 40 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K181439 (Boston Scientific Corporation, 2018) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K060269.
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. 2015, 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?
The SpyGlass DS Direct Visualization System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The SpyGlass DS Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter and the SpyGlass DS Digital Controller. The SpyScope DS Access and Delivery Catheter is intended to provide direct visualization and to guide…
Read the full statement (125 words)
The SpyGlass DS Direct Visualization System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The SpyGlass DS Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter and the SpyGlass DS Digital Controller.
The SpyScope DS Access and Delivery Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The SpyGlass DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142922: SpyGlass DS Direct Visualization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142922
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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