510(k) · Cleared
Cleared4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Edwards · LYK Angioscope
Cleared on Jul 28, 1995 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jul 28, 1995
- Review
- 49 days
- Class
- Class II
- Product code
- LYK
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK952638 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently…Baxter Edwards · 1995
- Descendant · cites it directly · 6 of its ownK023548 Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003
- Descendant · 2 generations on · 5 of its ownK042117 Proxis System, Model Eps 101Velocimed, Inc. · 2005
- Descendant · 3 generations on · 3 of its ownK060651 Proxis System, Model EPS101St Jude Medical · 2006
- Descendant · cites it directly · 3 of its ownK042381 Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004
- Descendant · 3 generations on · 2 of its ownK052523 Proxis SystemVelocimed, Inc. · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003 · cites it directly6descendants
- K042117Proxis System, Model Eps 101Velocimed, Inc. · 2005 · 2 generations on5descendants
- K060651Proxis System, Model EPS101St Jude Medical · 2006 · 3 generations on3descendants
- K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004 · cites it directly3descendants
- K052523Proxis SystemVelocimed, Inc. · 2006 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as… | Baxter Edwards | 1995 | — |
| +1 | K023548 | Proxis Flow-Control Device, Models Eps 101, IC 101 | Velocimed | 2003 | — |
| +2 | K042117 | Proxis System, Model Eps 101 | Velocimed, Inc. | 2005 | — |
| +3 | K060651 | Proxis System, Model EPS101 | St Jude Medical | 2006 | — |
| +1 | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | — |
| +3 | K052523 | Proxis System | Velocimed, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2026 | 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? (12)
See all 123 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?
- Of its descendants, K023548 (Velocimed, 2003) 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/K952638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952638: 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952638
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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