510(k) · Cleared
ClearedCardiooptics Augmentative Cardiac Optical Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio-Optics, Inc. · LYK Angioscope
Cleared on Nov 30, 2006 as substantially equivalent to K050808 (Cardio-Optics, Inc., 2005) and 4 other predicates after a 112-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Nov 30, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- LYK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K893658 (1989). 60 ancestors in all, the oldest K760385 (1976). No later device cites it as a predicate yet.
- Root · 8 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 7 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 6 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 5 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 4 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 3 generations backK032622 Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular · 2003
- 2 generations backK042381 Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004
- 1 generation backK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
- This deviceK062340 Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −7 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −6 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −5 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −4 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −3 | K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYS | Medtronic Vascular | 2003 | — |
| −2 | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | — |
| −1 | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | — |
| 0 (this device) | 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 | 5 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050808 | Coronary Sinus Access Kit, Model KCS8F-01Summary page 1…ac Optical Imaging System Common Name: Angioscope Classification Name: Angioscope (21 CFR 876.1500 Product Code: LYK) Predicate Devices: CSATM System, K050808 FSEA Fiberscope, K01 1763 Olympus Angioscopes, K91 1278 & K860858… | 2005 |
| Kept off the family tree | K011763 | FDA’s K011763 is Omnidos Our reading of the summary gave K011763, FDA’s number for Omnidos (Scanditronix Medical AB). Its FDA name has none of the distinctive words the summary uses for the device it names, “FSEA Fiberscope”. Kept off the family tree. Summary page 1…Angioscope Classification Name: Angioscope (21 CFR 876.1500 Product Code: LYK) Predicate Devices: CSATM System, K050808 FSEA Fiberscope, K01 1763 Olympus Angioscopes, K91 1278 & K860858 ACUSON AcuNaVTM 8F-1 10 Ultrasound Catheter… | 2001 |
| * | K911278 | Olympus AF Angioscope SystemSummary page 1…FR 876.1500 Product Code: LYK) Predicate Devices: CSATM System, K050808 FSEA Fiberscope, K01 1763 Olympus Angioscopes, K91 1278 & K860858 ACUSON AcuNaVTM 8F-1 10 Ultrasound Catheter, K042593 EPMed Systems ViewFl… | 1991 |
| * | K860858 | Olympus PF-18 & PF-25 Ultrathin AngioscopeSummary page 1…Product Code: LYK) Predicate Devices: CSATM System, K050808 FSEA Fiberscope, K01 1763 Olympus Angioscopes, K91 1278 & K860858 ACUSON AcuNaVTM 8F-1 10 Ultrasound Catheter, K042593 EPMed Systems ViewFlex Cathete… | 1986 |
| * | K042593 | Acuson Acunav 8F Ultrasound CatheterSummary page 1…FSEA Fiberscope, K01 1763 Olympus Angioscopes, K91 1278 & K860858 ACUSON AcuNaVTM 8F-1 10 Ultrasound Catheter, K042593 EPMed Systems ViewFlex Catheter, K031066 Device Description: The CardioOptics Augmentative Cardiac Op… | 2004 |
| * | K031066 | Viewmate Ultrasound Imaging SystemSummary page 1…ympus Angioscopes, K91 1278 & K860858 ACUSON AcuNaVTM 8F-1 10 Ultrasound Catheter, K042593 EPMed Systems ViewFlex Catheter, K031066 Device Description: The CardioOptics Augmentative Cardiac Optical Imaging System is composed of a si… | 2003 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 60 ancestors have a recall of any class.
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 Augmentative Cardiac Optical Imaging System is intended to image anatomical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging.
The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062340: Cardiooptics Augmentative Cardiac Optical Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062340
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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