510(k) · Cleared
ClearedVena MicroAngioscope™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vena Medical Holdings Corp · LYK Angioscope
Cleared on Oct 1, 2025 as substantially equivalent to K911278 (Olympus Corp., 1991) after a 113-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Oct 1, 2025
- Review
- 113 days
- Class
- Class II
- Product code
- LYK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911278 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK911278 Olympus AF Angioscope SystemOlympus Corp. · 1991 · Recalled
- This deviceK251767 Vena MicroAngioscope™ SystemVena Medical Holdings Corp · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911278 | Olympus AF Angioscope System | Olympus Corp. | 1991 | 1 |
| 0 (this device) | K251767 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp | 2025 | — |
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 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
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 |
|---|---|---|---|
| * | K911278 | Olympus AF Angioscope SystemSummary page 5…K III. PREDICATE DEVICE Trade Name: Olympus AF Angioscope System 510(k) Number: K911278 IV. DEVICE DESCRIPTION The Vena MicroAngioscope System consists of two main components: the Vena MicroAngioscopeTM (MA… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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 a recall.
- 3 other devices also cite its predicate K911278.
How does its category compare?
All LYK devicesLYK Angioscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Vena MicroAngioscope TM System is indicated for the observation of the interior of blood vessels of the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251767: Vena MicroAngioscope™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251767
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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