510(k) · Cleared
Cleared5 Star Medical Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Five Star Medical, Inc. · ODF Mini Endoscope, Gastroenterology-Urology
Cleared on Sep 8, 1997 after a 378-day review. The FDA summary names no predicate by number. 27 later devices descend from it.
- Decided
- Sep 8, 1997
- Review
- 378 days
- Class
- Class II
- Product code
- ODF
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK963354 5 Star Medical EndoscopeFive Star Medical, Inc. · 1997
- Descendant · cites it directly · 26 of its ownK050403 Spyglass Direct Visulation ProbeBoston Scientific Corp · 2005
- Descendant · 2 generations on · 20 of its ownK052194 Spyglass Direct Visualization Probe and OcularBoston Scientific Corp · 2005 · Recalled
- Descendant · 2 generations on · 11 of its ownK091962 Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic…Lumenis, Inc. · 2009
- Descendant · 3 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 3 generations on · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K050403Spyglass Direct Visulation ProbeBoston Scientific Corp · 2005 · cites it directly26descendants
- K052194Spyglass Direct Visualization Probe and OcularBoston Scientific Corp · 2005 · 2 generations on20descendants
- K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc. · 2009 · 2 generations on11descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 3 generations on10descendants
- K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963354 | 5 Star Medical Endoscope | Five Star Medical, Inc. | 1997 | — |
| +1 | K050403 | Spyglass Direct Visulation Probe | Boston Scientific Corp | 2005 | — |
| +2 | K052194 | Spyglass Direct Visualization Probe and Ocular | Boston Scientific Corp | 2005 | 2 |
| +2 | K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light… | Lumenis, Inc. | 2009 | — |
| +3 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +3 | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050403 | Spyglass Direct Visulation Probe | 2005 | 26 |
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?
- Of its descendants, K050403 (Boston Scientific Corp, 2005) has gone furthest, with 26 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 | — |
https://510kreport.com/device/K963354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963354: 5 Star Medical Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963354
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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