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 · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Jun 16, 2005 as substantially equivalent to K011149 (The Olympus Optical Co., 2001) and 1 other predicate after a 9-day review. Its family tree reaches back 2 generations to 1995. 11 later devices descend from it.
- Decided
- Jun 16, 2005
- Review
- 9 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950166 (1995). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950166 Olympus KD-6G1-9Q Wire Guided Papillotomu KnifeOlympus America, Inc. · 1995 · Recalled
- 1 generation backK011149 Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001
- This deviceK051504 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2005
- Descendant · cites it directly · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
- Descendant · 2 generations on · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
- Descendant · 3 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
- Descendant · 4 generations on · 5 of its ownK183636 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and…Boston Scientific Corporation · 2019
- Descendant · 5 generations on · 3 of its ownK200483 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital…Boston Scientific Corporation · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · cites it directly10descendants
- K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · 2 generations on9descendants
- K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 3 generations on7descendants
- K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation · 2019 · 4 generations on5descendants
- K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950166 | Olympus KD-6G1-9Q Wire Guided Papillotomu Knife | Olympus America, Inc. | 1995 | 10 |
| −1 | K011149 | Disposable Bending Cannula PR-233Q | The Olympus Optical Co. | 2001 | — |
| 0 (this device) | K051504 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2005 | — |
| +1 | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
| +2 | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | 1 |
| +3 | K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018 | — |
| +4 | K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery… | Boston Scientific Corporation | 2019 | — |
| +5 | K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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.
Planning a device in FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K011149 | Disposable Bending Cannula PR-233Q | 2001 |
| * | K944473 | XCHF-33 CholedochofiberscopeSummary page 1…Classification Name: Endoscopes and Accessories 3. Predicate Device: Olymnpus SwingTip Cannula, K0I 1149 Olympus ClIP Type BP30 Choledochiofiberscope, K944473 4. Device Description: The SpyScope Access and Delivery Catheter is a sterile, single-use device comprised of tw… | 1995 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090170 | Spyscope Access and Delivery Catheter | 2009 | 10 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K090170 (Boston Scientific Corp, 2009) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K011149.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 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 biliary system including the hepatic ducts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051504 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051504: Spyscope Access and Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051504
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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