510(k) · Cleared
ClearedCoronary Sinus Access Kit, Model KCS8F-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio-Optics, Inc. · LYK Angioscope
Cleared on Jul 28, 2005 as substantially equivalent to K911278 (Olympus Corp., 1991) and 5 other predicates after a 120-day review. Its family tree reaches back 7 generations to 1989. 1 later device descends from it.
- Decided
- Jul 28, 2005
- Review
- 120 days
- Class
- Class II
- Product code
- LYK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K893658 (1989). 52 ancestors in all, the oldest K760385 (1976). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 6 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 5 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 4 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 3 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 2 generations backK032622 Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular · 2003
- 1 generation backK042381 Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004
- This deviceK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK062340 Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −6 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −5 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −4 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −3 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −2 | K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYS | Medtronic Vascular | 2003 | — |
| −1 | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | — |
| 0 (this device) | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | — |
| +1 | K062340 | Cardiooptics Augmentative Cardiac Optical Imaging System | Cardio-Optics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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 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? (6)
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 1…scope Product code LYK, CFR Section 876.1500 Predicate Devices: Primary Predicate Devices: Olympus Angioscopes, K91 1278 & K860858 Product code LYK, CFR Section 876.1500 Additional Predicate Devic… | 1991 |
| * | K860858 | Olympus PF-18 & PF-25 Ultrathin AngioscopeSummary page 1…Product code LYK, CFR Section 876.1500 Predicate Devices: Primary Predicate Devices: Olympus Angioscopes, K91 1278 & K860858 Product code LYK, CFR Section 876.1500 Additional Predicate Devices:'… | 1986 |
| * | K955817 | Coridis Webster Deflectable Braided-Tip Electrode CatheterSummary page 1…Product code LYK, CFR Section 876.1500 Additional Predicate Devices:' Biosense Webster CS Deflectable Catheter K955817 Product code DRF, CFR Section 870.1220 St. Jude Medical Apeel TM CS Guide S… | 1996 |
| * | K031906 | Apeel CS Catheter Delivery SystemSummary page 1…er CS Deflectable Catheter K955817 Product code DRF, CFR Section 870.1220 St. Jude Medical Apeel TM CS Guide Sheath K031906 Product code DYB, CFR Section 870.1340 Thomas Medical SafeSheath TM CS Shea… | 2003 |
| * | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveSummary page 1…cal Apeel TM CS Guide Sheath K031906 Product code DYB, CFR Section 870.1340 Thomas Medical SafeSheath TM CS Sheaths K003731 Product code DYB, CFR Section 870.1340 Acumen Coronary Sinus Visualization… | 2001 |
| * | K042381 | Coronary Sinus Visualization System, Model CSVS5508Summary page 1…SafeSheath TM CS Sheaths K003731 Product code DYB, CFR Section 870.1340 Acumen Coronary Sinus Visualization System, K042381 Product code DQY, CFR Section 870.1250 Device Description: The Coronary Sinus Access (CSA TM)… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062340 | Cardiooptics Augmentative Cardiac Optical Imaging System | 2006 | 0 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 52 ancestors have a recall of any class.
- Of its descendants, K062340 (Cardio-Optics, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 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.
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 CardioOptics Coronary Sinus Access (CSATM ) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a guide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050808: Coronary Sinus Access Kit, Model KCS8F-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050808
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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