510(k) · Cleared
ClearedSphere-9Dx Diagnostic Catheter (AFR-00009)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Aug 7, 2024 as substantially equivalent to K201750 (Biosense Webster, Inc., 2020) after a 300-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Aug 7, 2024
- Review
- 300 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K983171 (1999). 13 ancestors in all, the oldest K970264 (1997). No later device cites it as a predicate yet.
- Root · 7 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 6 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 5 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 4 generations backK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- 3 generations backK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- 2 generations backK123837 Pentaray Nav Eco High-Density Mapping CatheterBiosense Webster, Inc. · 2013 · Recalled
- 1 generation backK201750 Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc. · 2020
- This deviceK233433 Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −6 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −5 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −4 | 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 |
| −2 | K123837 | Pentaray Nav Eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2013 | 5 |
| −1 | K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020 | — |
| 0 (this device) | K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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 MTD? 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? (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 |
|---|---|---|---|
| * | K201750 | Pentaray Nav eco High-Density Mapping CatheterSummary page 5…s II, 21 CFR 870.1220, Cardiovascular Product Code: MTD Predicate Device: PENTARAY Nav eco High Density Mapping Catheter (K201750) Device Description: The Sphere-9Dx Diagnostic catheter (AFR-00009) is a steerable irrigated mul… | 2020 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K201750.
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. 2024, this device’s year, is highlighted.
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?
The Sphere-9Dx Diagnostic Catheter is indicated for electrophysiological mapping (recording and stimulation) of cardiac structures in the heart. This catheter is intended to obtain electrograms in the atrial regions of the heart. The catheter provides location information when used with a compatible Affera Mapping System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233433: Sphere-9Dx Diagnostic Catheter (AFR-00009).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233433
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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