510(k) · Cleared
ClearedSpyscope Access and Delivery Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · ODF Mini Endoscope, Gastroenterology-Urology
Cleared on Feb 4, 2009 as substantially equivalent to K051504 (Boston Scientific Corp, 2005) and 4 other predicates after a 12-day review. Its family tree reaches back 5 generations to 1993. 1 of the 27 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Feb 4, 2009
- Review
- 12 days
- Class
- Class II
- Product code
- ODF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K931154 (1993). 16 ancestors in all, the oldest K904799 (1991). 10 later devices descend from it, 1 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- 2 generations backK033225 Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its…Olympus Optical Co., Ltd. · 2003 · Recalled
- 1 generation backK051886 Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005
- This deviceK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
- Descendant · cites it directly · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
- Descendant · 2 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
- Descendant · 3 generations on · 5 of its ownK183636 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and…Boston Scientific Corporation · 2019
- Descendant · 4 generations on · 3 of its ownK200483 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital…Boston Scientific Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK221784 Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…3 generations back · 2003
Most influential descendants
Showing 5 of 10 · See all- K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · cites it directly9descendants
- K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 2 generations on7descendants
- K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation · 2019 · 3 generations on5descendants
- K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation · 2020 · 4 generations on3descendants
- K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| −2 | K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and… | Olympus Optical Co., Ltd. | 2003 | 5 |
| −1 | K051886 | Olympus Choledochoscope, Model XCHF-BP160F | Olympus Medical Systems Corporation | 2005 | — |
| 0 (this device) | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
| +1 | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | 1 |
| +2 | K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018 | — |
| +3 | K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery… | Boston Scientific Corporation | 2019 | — |
| +4 | K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | 2020 | — |
| +2 | K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K051504 | Spyscope Access and Delivery CatheterSummary page 1…essories Regulation Number: 876.1500 Product Code: KOG Classification: Class II 3. Predicate Devices SpyScope Access'and Delivery Catheter, K05 1504 Wilson-Cook Pancreatic Wedge Stents, K990130 Olympus (SwingTip) Disposable Bending Cannula PR-233Q, K01 1149… | 2005 |
| * | K990130 | Wilson-Cook Pancreatic Wedge StentSummary page 1…oduct Code: KOG Classification: Class II 3. Predicate Devices SpyScope Access'and Delivery Catheter, K05 1504 Wilson-Cook Pancreatic Wedge Stents, K990130 Olympus (SwingTip) Disposable Bending Cannula PR-233Q, K01 1149 SpyGlass Direct Visualization Probe, K052 194… | 1999 |
| * | K011149 | Disposable Bending Cannula PR-233QSummary page 1…SpyScope Access'and Delivery Catheter, K05 1504 Wilson-Cook Pancreatic Wedge Stents, K990130 Olympus (SwingTip) Disposable Bending Cannula PR-233Q, K01 1149 SpyGlass Direct Visualization Probe, K052 194 Olympus XCHF-BP 16F Choledochoscope, K05 1886 .4. Device Description… | 2001 |
| * | K052194 | Spyglass Direct Visualization Probe and OcularSummary page 1…04 Wilson-Cook Pancreatic Wedge Stents, K990130 Olympus (SwingTip) Disposable Bending Cannula PR-233Q, K01 1149 SpyGlass Direct Visualization Probe, K052 194 Olympus XCHF-BP 16F Choledochoscope, K05 1886 .4. Device Description The SpyS cope Access and Delivery Catheter is a ste… | 2005 |
| * | K051886 | Olympus Choledochoscope, Model XCHF-BP160FSummary page 1…0 Olympus (SwingTip) Disposable Bending Cannula PR-233Q, K01 1149 SpyGlass Direct Visualization Probe, K052 194 Olympus XCHF-BP 16F Choledochoscope, K05 1886 .4. Device Description The SpyS cope Access and Delivery Catheter is a sterile, single-use device comprised of two main compone… | 2005 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142922 | SpyGlass DS Direct Visualization System | 2015 | 9 |
Has anything in its family been recalled? (1 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 3 generations back · ◆ on the line of descent in FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K142922 (Boston Scientific Corporation, 2015) has gone furthest, with 9 descendants of its own.
How does its category compare?
All ODF devicesODF Mini Endoscope, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ODF
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · ODF
Too few ODF 510(k)s in any year since 2007 to give a median.
Recalls per year · ODF
No recall names ODF since 2007.
Adverse event reports per year · ODF
1in 2022
MAUDE reports naming product code ODF, 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 | 5 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices 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/K090170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090170: Spyscope Access and Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090170
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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