510(k) · Cleared
Recalled · Class III · 2023Olympus AF Angioscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · LYK Angioscope
Cleared on Jul 17, 1991 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled once.
- Decided
- Jul 17, 1991
- Review
- 114 days
- Class
- Class II
- Product code
- LYK
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK911278 Olympus AF Angioscope SystemOlympus Corp. · 1991
- Descendant · cites it directly · 6 of its ownK070752 Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK082569 Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008
- Descendant · 3 generations on · 3 of its ownK162916 3NT endoscopy system3nt Medical, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK251767 Vena MicroAngioscope™ SystemVena Medical Holdings Corp · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K070752Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc. · 2007 · cites it directly6descendants
- K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008 · 2 generations on5descendants
- K1629163NT endoscopy system3nt Medical, Ltd. · 2017 · 3 generations on3descendants
- K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005 · cites it directly1descendant
- K251767Vena MicroAngioscope™ SystemVena Medical Holdings Corp · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911278 | Olympus AF Angioscope System | Olympus Corp. | 1991 | — |
| +1 | K070752 | Ksea Miniature Endoscope, Model 11565 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +2 | K082569 | Entellus Medical Flexible Endoscope and Eyepiece | Entellus Medical, Inc. | 2008 | — |
| +3 | K162916 | 3NT endoscopy system | 3nt Medical, Ltd. | 2017 | — |
| +1 | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | — |
| +1 | K251767 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYK? 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 LYK device
- #1 K253842 Vena MicroAngioscope™ Systemscore 10.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 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 |
|---|---|---|---|---|
| Sep 25, 2023 | Class III | Z-0330-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070752 (KARL STORZ Endoscopy-America, Inc., 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LYK devicesLYK Angioscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYK
Too few LYK 510(k)s in any year since 2007 to give a median.
Recalls per year · LYK
No recall names LYK since 2007.
Adverse event reports per year · LYK
1in 2024
MAUDE reports naming product code LYK, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K911278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K911278: Olympus AF Angioscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K911278
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026