510(k) · Decided
Recalled · 2005Constellation Catheters, Model 8031M
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 May 16, 2002 as substantially equivalent to K983171 (Boston Scientific Corp, 1999) and 3 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1999. 1 of the 59 devices in its family, counting itself, has a Class I recall. 54 later devices descend from it. It has been recalled once.
- Decided
- May 16, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- MTD
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K983171 (1999). 4 ancestors in all. 54 later devices descend from it, 3 citing it directly. 1 of the 59 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 1 generation backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- This deviceK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002
- Descendant · cites it directly · 39 of its ownK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- Descendant · 2 generations on · 34 of its ownK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
- Descendant · 4 generations on · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- Descendant · 5 generations on · 13 of its ownK212061 EnSite X EP SystemAbbott · 2021
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…6 generations on · 2024
Most influential descendants
Showing 5 of 54 · See all- K050217Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode…Biosense Webster, Inc. · 2005 · cites it directly39descendants
- K120425Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · 2 generations on34descendants
- K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · 3 generations on21descendants
- K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · 4 generations on17descendants
- K212061EnSite X EP SystemAbbott · 2021 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −1 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| 0 (this device) | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | — |
| +1 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| +2 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| +3 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
| +4 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| +5 | K212061 | EnSite X EP System | Abbott | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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 16.5 · 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? (4)
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 |
|---|---|---|---|
| * | K983171 | Constellation Multiple Electrode Pacing and Recording SystemSummary page 2…. Technological Characteristics: The modified Constellaion® catheter features identical technological characteristics to currently approved Constellation® models under K983171, K992777, K000277, and K003782. The only new characteristic of the proposed Constellation® model 8031M is electrode spacing reduc… | 1999 |
| * | K992777 | Constellation Catheters, Model 8039Summary page 2…logical Characteristics: The modified Constellaion® catheter features identical technological characteristics to currently approved Constellation® models under K983171, K992777, K000277, and K003782. The only new characteristic of the proposed Constellation® model 8031M is electrode spacing reduced from a… | 1999 |
| * | K000277 | Constellation CathetersSummary page 2…haracteristics: The modified Constellaion® catheter features identical technological characteristics to currently approved Constellation® models under K983171, K992777, K000277, and K003782. The only new characteristic of the proposed Constellation® model 8031M is electrode spacing reduced from a range be… | 2000 |
| * | K003782 | Constellation Catheter, Model 8031Summary page 2…s: The modified Constellaion® catheter features identical technological characteristics to currently approved Constellation® models under K983171, K992777, K000277, and K003782. The only new characteristic of the proposed Constellation® model 8031M is electrode spacing reduced from a range between 2 - 13m… | 2001 |
What descends from it? (54)
See all 543 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 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K050217 (Biosense Webster, Inc., 2005) has gone furthest, with 39 descendants of its own.
- 2 other devices also cite its predicate K983171.
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 | — |
What is it indicated for?
For use in right atrial electrophysiology procedures to assist in the diagnosis of complex arthythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation® Multiple Electrode Recording and Pacing Catheters System may also be used for delivery of externally generated pacing stimuli.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021232: Constellation Catheters, Model 8031M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021232
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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