510(k) · Cleared
ClearedAcumen Insight Endocardial Visualization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumen Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Apr 6, 2007 as substantially equivalent to K042381 (Acumen Medical, Inc., 2004) and 2 other predicates after a 92-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Apr 6, 2007
- Review
- 92 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K893658 (1989). 52 ancestors in all, the oldest K760385 (1976). No later device cites it as a predicate yet.
- 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 deviceK070051 Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007
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) | K070051 | Acumen Insight Endocardial Visualization System | Acumen Medical, Inc. | 2007 | — |
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 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K042381 | Coronary Sinus Visualization System, Model CSVS5508Summary page 1…of the heart. The Insight is intended for use in the right heart only. Predicate Devices Acumen Insight Endocardial Visualization System K042381, K062084 Manufactured by Acumen Medical, Inc. AcuNav Diagnostic Ultrasound Catheter… | 2004 |
| * | K062084 | 7F Acumen Coronary Sinus Visualization System, Model CSVS-7-67Summary page 1…eart. The Insight is intended for use in the right heart only. Predicate Devices Acumen Insight Endocardial Visualization System K042381, K062084 Manufactured by Acumen Medical, Inc. AcuNav Diagnostic Ultrasound Catheter K992… | 2006 |
| * | K992631 | Acunav Diagnostic Ultrasound CatheterSummary page 1…K042381, K062084 Manufactured by Acumen Medical, Inc. AcuNav Diagnostic Ultrasound Catheter K992631 Manufactured by Acuson Corporation Device Description The Acumen Insight Endocardial Visualization System (Insight) is… | 1999 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 52 ancestors have a recall of any class.
- 1 other device also cites its predicate K042381.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The Insight is intended for use in the right heart only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070051: Acumen Insight Endocardial Visualization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070051
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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