510(k) · Cleared
Recalled · 2007Spyglass Direct Visualization Probe and Ocular
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 Aug 24, 2005 as substantially equivalent to K050403 (Boston Scientific Corp, 2005) after a 13-day review. Its family tree reaches back 2 generations to 1997. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 24, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- ODF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963354 (1997). 20 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK963354 5 Star Medical EndoscopeFive Star Medical, Inc. · 1997
- 1 generation backK050403 Spyglass Direct Visulation ProbeBoston Scientific Corp · 2005
- This deviceK052194 Spyglass Direct Visualization Probe and OcularBoston Scientific Corp · 2005
- Descendant · cites it directly · 10 of its ownK090170 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 · cites it directly · 8 of its ownK122042 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2012
- Descendant · 2 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
- Descendant · 2 generations on · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · cites it directly10descendants
- K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · cites it directly9descendants
- K122042Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2012 · cites it directly8descendants
- K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 2 generations on7descendants
- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963354 | 5 Star Medical Endoscope | Five Star Medical, Inc. | 1997 | — |
| −1 | K050403 | Spyglass Direct Visulation Probe | Boston Scientific Corp | 2005 | — |
| 0 (this device) | K052194 | Spyglass Direct Visualization Probe and Ocular | Boston Scientific Corp | 2005 | — |
| +1 | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
| +1 | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | 1 |
| +1 | K122042 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2012 | — |
| +2 | K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018 | — |
| +2 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K050403 | Spyglass Direct Visulation ProbeSummary page 1…be Common Name: Mini-Endoscope Classification Name: Flexible Endoscope 3. Predicate Devices: Boston Scientific, SpyGlass Direct Visualization Probe - K050403 4. Device Description: The proposed SpyGlass Direct Visualization Probe a fiberoptic endoscope. The proposed device… | 2005 |
What descends from it? (20)
See all 203 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2007 | Not classified | Z-0697-2007 | Other | SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe |
| Feb 7, 2007 | Not classified | Z-0696-2007 | Other | SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090170 (Boston Scientific Corp, 2009) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K050403.
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 as stated in the FDA summary.
https://510kreport.com/device/K052194 · printed Nov 3, 2026
Cite this page
510(k) Report. “K052194: Spyglass Direct Visualization Probe and Ocular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052194
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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