510(k) · Cleared
Recalled · 2005Constellation Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Sep 26, 2000 after a 239-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 56 devices in its family, counting itself, has a Class I recall. 55 later devices descend from it. It has been recalled once.
- Decided
- Sep 26, 2000
- Review
- 239 days
- Class
- Class II
- Product code
- MTD
- Recalls
- 1
- Predicates
- 0
55 later devices descend from it, 2 citing it directly. 1 of the 56 devices in this family, counting this one, has a Class I recall.
- This deviceK000277 Constellation CathetersBoston Scientific Corp · 2000
- Descendant · cites it directly · 54 of its ownK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- Descendant · 2 generations on · 39 of its ownK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- Descendant · 3 generations on · 34 of its ownK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
- Descendant · 5 generations on · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…7 generations on · 2024
Most influential descendants
Showing 5 of 55 · See all- K021232Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · cites it directly54descendants
- K050217Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode…Biosense Webster, Inc. · 2005 · 2 generations on39descendants
- K120425Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · 3 generations on34descendants
- K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · 4 generations on21descendants
- K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000277 | Constellation Catheters | Boston Scientific Corp | 2000 | — |
| +1 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| +2 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| +3 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| +4 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
| +5 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 1 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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.
1 device in this family has a Class I recall. 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 MTD device
- #1 K231312 PENTARAY® NAV ECO High Density Mapping…score 16.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (55)
See all 552 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2005 | Not classified | Z-0639-05 | Other | The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K021232 (Boston Scientific Corp, 2002) has gone furthest, with 54 descendants of its own.
How does its category compare?
All MTD devicesMTD Catheter, Intracardiac Mapping, High-Density Array: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MTD
66in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTD
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTD
385in 2025
MAUDE reports naming product code MTD, 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 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 2 | — | 0 | 17 |
| 2013 | 2 | — | 0 | 30 |
| 2014 | 2 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 2 | 38 |
| 2018 | 1 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 77 |
| 2020 | 4 | 169 | 0 | 87 |
| 2021 | 1 | — | 0 | 99 |
| 2022 | 2 | — | 0 | 145 |
| 2023 | 3 | 66 | 0 | 184 |
| 2024 | 2 | — | 0 | 378 |
| 2025 | 0 | — | 0 | 385 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K000277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000277: Constellation Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000277
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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