510(k) · Cleared
ClearedCPS Locator 3D Plus Delivery Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CenterPoint Systems, LLC · DQY Catheter, Percutaneous
Cleared on Jul 29, 2026 as substantially equivalent to K250828 (CenterPoint Systems, LLC, 2025) after a 62-day review. Its family tree reaches back 13 generations to 1989.
- Decided
- Jul 29, 2026
- Review
- 62 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K893658 (1989). 60 ancestors in all, the oldest K760385 (1976). No later device cites it as a predicate yet.
- Root · 13 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 9 generations between
- 3 generations backK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
- 2 generations backK230363 CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023
- 1 generation backK250828 CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2025
- This deviceK261766 CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
Show all 13 generations
- Root · 13 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 12 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 11 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 10 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 9 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 8 generations backK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- 7 generations backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- 6 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 5 generations backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- 4 generations backK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- 3 generations backK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
- 2 generations backK230363 CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023
- 1 generation backK250828 CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2025
- This deviceK261766 CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −12 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −11 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −10 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −9 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −8 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| −7 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | — |
| −6 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
| −5 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
| −4 | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | 1 |
| −3 | K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3… | Centerpoint Systems | 2019 | — |
| −2 | K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | 2023 | — |
| −1 | K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025 | — |
| 0 (this device) | K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026 | — |
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 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K250828 | CPS Locator 3D Plus Delivery CatheterSummary page 5…Class II per 21 CFR 870.1250 Product Code: DQY 1.3 Predicate Device Predicate Name and 510(k) Number: CPS Locator 3D Plus Delivery Catheter, K250828 This predicate has not been subject to a design-related recall. The reference device, CPS Locator 3D Delivery Catheter, K250147,… | 2025 |
| † | K250147 | CPS Locator 3D Delivery Catheter | 2025 |
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 37 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 11 of the 60 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads to the right heart, inclusive of the Left Bundle Branch Area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261766: CPS Locator 3D Plus Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261766
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026