510(k) · Cleared
ClearedSpyglass Direct Visulation Probe
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 Mar 4, 2005 as substantially equivalent to K963354 (Five Star Medical, Inc., 1997) after a 15-day review. Its family tree reaches back 1 generation to 1997. 26 later devices descend from it.
- Decided
- Mar 4, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- ODF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963354 (1997). 26 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK963354 5 Star Medical EndoscopeFive Star Medical, Inc. · 1997
- This deviceK050403 Spyglass Direct Visulation ProbeBoston Scientific Corp · 2005
- Descendant · cites it directly · 20 of its ownK052194 Spyglass Direct Visualization Probe and OcularBoston Scientific Corp · 2005 · Recalled
- Descendant · cites it directly · 11 of its ownK091962 Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic…Lumenis, Inc. · 2009
- Descendant · 2 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 2 generations on · 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
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K052194Spyglass Direct Visualization Probe and OcularBoston Scientific Corp · 2005 · cites it directly20descendants
- K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc. · 2009 · cites it directly11descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 2 generations on10descendants
- K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · 2 generations on10descendants
- K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963354 | 5 Star Medical Endoscope | Five Star Medical, Inc. | 1997 | — |
| 0 (this device) | K050403 | Spyglass Direct Visulation Probe | Boston Scientific Corp | 2005 | — |
| +1 | K052194 | Spyglass Direct Visualization Probe and Ocular | Boston Scientific Corp | 2005 | 2 |
| +1 | K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light… | Lumenis, Inc. | 2009 | — |
| +2 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +2 | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
| +2 | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 ODF? 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K830393 | FDA’s K830393 is Providone-Iodine Swabsticks Our OCR of the scanned summary read K830393, FDA’s number for Providone-Iodine Swabsticks (H & P Industries, Inc.), which shares no word with the summary’s name for the device, “Visicath Imaging Catheter”, apart from generic ones like “system”. Kept off the family tree. Summary page 1…ss™ Direct Visualization Probe Common Name: Mini-Endoscope Classification Name: Flexible Endoscope 3. Predicate Devices: Boston Scientific, Visicath Imaging Catheter - K830393 3 Star Medical, Saratoga Modular Miniature Endoscope - K963354 4. Device Description: The proposed SpyGlass™ Direct Visualizati… | 1983 |
| * | K963354 | 5 Star Medical EndoscopeSummary page 1…sification Name: Flexible Endoscope 3. Predicate Devices: Boston Scientific, Visicath Imaging Catheter - K830393 3 Star Medical, Saratoga Modular Miniature Endoscope - K963354 4. Device Description: The proposed SpyGlass™ Direct Visualization Probe a fiberoptic endoscope. Therc is a glass lens at the d… | 1997 |
What descends from it? (26)
See all 264 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K052194 (Boston Scientific Corp, 2005) has gone furthest, with 20 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.
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 proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
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/K050403 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050403: Spyglass Direct Visulation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050403
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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